A Retrospective Analysis of the Effectiveness and Safety of Plerixafor Combined with PEGylated rhG-CSF for Autologous Hematopoietic Stem Cell Mobilization in  Patients with Multiple Myeloma

A Retrospective Analysis of the Effectiveness and Safety of Plerixafor Combined with PEGylated rhG-CSF for Autologous Hematopoietic Stem Cell Mobilization in Patients with Multiple Myeloma | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article A Retrospective Analysis of the Effectiveness and Safety of Plerixafor Combined with PEGylated rhG-CSF for Autologous Hematopoietic Stem Cell Mobilization in Patients with Multiple Myeloma Juan Zhuang, Zhenting Ma, Bingqi Hou, Linjuan Zeng, Bixiang Li, and 9 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6261556/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose The study aims to assess the clinical efficacy and safety profile of plerixafor in combination with polyethylene glycolated recombinant human granulocyte colony-stimulating factor (PEGylated rhG-CSF) for autologous hematopoietic stem cell (auto-HSC) mobilization in patients diagnosed with multiple myeloma (MM). Methods A retrospective analysis was conducted to evaluate the stem cell collection efficiency, post-transplant hematopoietic reconstitution, and mobilization-related adverse events in a cohort of 18 MM patients who underwent stem cell mobilization using the combination of plerixafor and PEGylated rhG-CSF. Successful mobilization was defined as achieving or surpassing a threshold of 2.0×10 6 /kg. An excellent mobilization is characterized by achieving a yield of at least 5.0×10 6 /kg. Results Our results revealed an overall stem cell collection success rate of 100%. Notably, 72% of patients achieved successful mobilization within the first day. Furthermore, the overall excellent collection rate was 56%, with a 1-day excellent collection rate of 27%. The median number of collected CD34+ cells was 5.62(2-16.19)×106/kg. The most frequently encountered adverse events were bone pain (11%), nausea and vomiting (11%), and diarrhea (11%), all classified as grade 1-2. All patients underwent auto-HSC transplantation, with a median engraftment time of 11 (ranging from 9 to 14) days for neutrophils and 14 (ranging from 10 to 20) days for platelets, respectively. Conclusion In conclusion, this is the first report of the combination of PEGylated rhG-CSF and plerixafor for auto-HSC mobilization and collection in patients with MM, and the results show good mobilization success rate and safety. Plerixafor PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor Multiple Myeloma Autologous hematopoietic stem cell mobilization Efficacy and Safety Introduction High-dose chemotherapy coupled with autologous peripheral blood (PB) hematopoietic stem cell transplantation serves as a pivotal therapeutic modality for hematopoietic system tumors and has become the standard first-line treatment for multiple myeloma (MM), significantly prolonging patient survival and improving prognosis [ 1 ]. Ensuring an adequate yield of hematopoietic stem cells (HSCs) is critical for successful transplantation. Current mobilization strategies include granulocyte colony-stimulating factor (rhG-CSF) alone, chemotherapy combined with rhG-CSF, and plerixafor paired with rhG-CSF. While rhG-CSF remains the standard agent for PB HSC mobilization, the addition of chemotherapy may enhance mobilization efficacy but introduces prolonged timelines, multiple apheresis sessions, and chemotherapy-related toxicities [ 2 , 3 ]. These drawbacks amplify healthcare costs and logistical burdens [ 3 , 4 ]. A pivotal phase III trial (DiPersio et al. 2009) established the efficacy of plerixafor + rhG-CSF for first-line steady-state mobilization in MM patients, demonstrating superior CD34 + cell yields compared to rhG-CSF alone [ 5 ]. Subsequent post hoc analyses and observational studies further supported its utility in reducing apheresis days and improving mobilization success rates [ 6 , 7 ]. However, rhG-CSF requires daily injections, posing practical challenges for patients and healthcare providers. In contrast, PEGylated rhG-CSF-a long-acting formulation with an extended half-life—enables sustained mobilization via a single injection, simplifying administration and aligning with resource-constrained clinical settings [ 8 ]. Emerging evidence suggests that combining PEGylated rhG-CSF with plerixafor may optimize mobilization efficiency while minimizing burdensome protocols [ 9 , 10 ]. In China, challenges such as limited access to repeated apheresis and patient preference for fewer injections motivated the upfront use of PEGylated rhG-CSF + plerixafor, even in patients without prior mobilization failure. This strategy aligns with global trends favoring fixed-day protocols to reduce healthcare resource utilization [ 11 , 12 ]. Early adoption of this combination may also preempt mobilization failure in high-risk MM populations, such as elderly patients or those with extensive prior therapy. Despite promising data from Western cohorts, evidence for PEGylated rhG-CSF + plerixafor in Chinese MM patients remains scarce. This study aims to address this gap by evaluating the efficacy and safety of this regimen in a Chinese clinical context. Patients and methods Between December 2021 and June 2024, a total of 20 patients with multiple myeloma (MM) underwent autologous peripheral blood (PB) hematopoietic stem cell mobilization at the Fifth Affiliated Hospital of Sun Yat-sen University, utilizing a regimen of PEGylated rhG-CSF (CSPC Pharmaceutical Group Co., Ltd., Yantai, China) combined with plerixafor (Yifan Biopharmaceutical Co., Ltd., Hefei, China). The diagnosis of MM was confirmed based on a comprehensive evaluation encompassing bone marrow morphology, immunology, cytogenetics, molecular biology, as well as imaging modalities such as enhanced computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET-CT). This study was conducted in accordance with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the Fifth Affiliated Hospital of Sun Yat-sen University (No. SY5H [2025] Ethical Review (k89-1)). Treatment Referring to domestic and international treatment guidelines for MM, induction therapy typically employs a bortezomib-based three-drug combination regimen, such as VRd, DPd, VCD, etc. Considering the disease subtype, stage, and molecular biology characteristics of the patient, auto-HSC mobilization and collection are typically performed after approximately four courses of treatment, contingent upon the patient's remission status. Mobilization and Collection Protocol Mobilization and Collection Protocol PEGylated rhG-CSF + Plerixafor mobilization protocol: ①PEG-rhG-CSF 12mg subcutaneous injection on Day 1, and rhG-CSF 10 µg·kg − 1 ·d − 1 administered at 6:00 AM on the day of collection, for a maximum of 3 consecutive days. ②Plerixafor 1.2 ml (2.4mg), subcutaneous injection at 22:00 on Day 4. ③PB hematopoietic stem cell collection using blood cell separator (Spectra Optia,Terumo BCT, Inc.,Japan) begins at 9:00 on Day 5, accompanied by CD34 + cell which are measured by flow cytometry (Beckman Coulter, Beckman Coulter Biotechnology (Suzhou) Co., Ltd., China) and mononuclear cell (MNC) counting. The target for auto-HSC collection is CD34 + cells ≥ 2.0×10 6 /kg. Successful collection is defined as CD34 + cells ≥ 2.0×10 6 /kg, and the excellent collection is CD34 + cells ≥ 5.0×10 6 /kg. For this analysis, we defined mobilization failure as a cumulative yield of CD34 + cells < 2.0×10 6 /kg, the minimum cell dose considered acceptable for once transplantation [ 10 ]. Pretreatment protocol and engraftment criteria for auto-HSCT MM pretreatment regimen: Melphalan 200mg/m 2 (if creatinine clearance is < 60%, the dose is reduced to 140mg/m 2 ), administered over 2 days, starting on day − 3. rhG-CSF 5ug·kg − 1 ·d − 1 is given from day + 3 until granulocyte reconstitution. Implantation criteria: Neutrophil engraftment is defined as an absolute neutrophil count (ANC) ≥ 0.5 × 10 9 /L for 3 consecutive days; platelet engraftment is defined as a platelet count (PLT) ≥ 20.0 × 10 9 /L for 7 consecutive days and independence from platelet transfusion. Definitions, Efficacy Evaluation Criteria, and Safety Assessment The efficacy evaluation of MM was previously described in detail [ 11 , 12 ], and adverse reactions are graded according to the CTCAE version 5.0 classification standard. Statistical analysis Descriptive statistical analysis was performed using SPSS 26.0 software. Numerical variables were described as means (± standard deviation). Skewed numerical variables were described as medians (ranges). Results Clinical Characteristics A total of 18 MM patients underwent mobilization with PEGylated rhG-CSF + plerixafor. Their median age was 59 years old (range: 35–66 years old), including 11 males and 7 females. Before mobilization, the median number of chemotherapy cycles received by these patients was 4, with a range from 3 to 19 cycles. Among these patients, 12 had undergone ≤ 4 cycles of chemotherapy before mobilization. Three patients had a history of previous chemotherapy combined with rhG-CSF mobilization. Of these three, two patients failed to achieve successful mobilization, while the third patient had successful mobilization but later experienced disease relapse. They were re-mobilized with PEGylated rhG-CSF + plerixafor before undergoing salvage transplantation. The median time from diagnosis to mobilization was 4.5 months (range: 3–39 months). The general characteristics of all patients are shown in Table 1 . Table 1 Clinical Characteristics Characteristics MM Number 18 Median age (range), years 59(35–66) Male 11(61) Female 7(39) Median no. of induction cycles(range) 4(3–19) No. of induction cycles, n (%) ≤4 12(67) >4 6(33) Median cycles of lenalidomide (range) 4(0–6) Mobilizer status, n (%) CR 8(44) PR 8(44) PD 2(11) Previous chemotherapy mobilization, n (%) 3(17) Median time from diagnosis to consent, months 4.5(3–39) Results of auto-HSC Collection The overall success rate of stem cell collection was 100%, with a 1-day collection success rate of 72% and a 2-day collection success rate of 94%. The overall collection excellence rate was 56%, and the 1-day collection excellence rate was 27%. The median CD34 + yield of all patients was 5.62 (2-16.19) × 10 6 /kg, and the median CD34 + yield on first day of collection was 3.21 (0.61–7.75) × 10 6 /kg. Median CD34 + number in PB on first day of collection was 78 (5-188) cells/µl. Detailed data is presented in Table 2 . Table 2 Results of auto-HSC Collection Outcome MM (n = 18) Patients reaching ⩾ 2 × 106/kg CD34 + cells, n (%) 18(100) Patients reaching ⩾ 2 × 106/kg CD34 + cells in 1 collection, n (%) 13(72) Patients reaching ⩾ 2 × 106/kg CD34 + cells in 2 collection,n (%) 17(94) Patients reaching ⩾ 5 × 106/kg CD34 + cells,n (%) 10(56) Patients reaching ⩾ 5 × 106/kg CD34 + cells in 1 collection,n (%) 5(27) Patients reaching ⩾ 5 × 106/kg CD34 + cells in 2 collection,n (%) 10(56) Cumulative CD34 + cell yield, ×106/kg, median (range) 5.62(2-16.19) CD34 + yield on first day of collection, ×106/kg, median (range) 3.21(0.61–7.75) CD34 + cells/uL in PB on first day of collection, median (range) 78(5-188) Transplantation Status and Hematopoietic Reconstitution As of now, 18 patients underwent auto-HSCT. The median of CD34 + HSPCs infused for auto-HSCT was 3.41 (2-6.25)×10 6 /kg. The neutrophil engraftment time was 11 (9–14) days, and the platelet engraftment time was 14 (10–20) days. The time to hematopoietic reconstitution were consistent with contemporary outcomes. Information on transplantation status and hematopoietic reconstitution is presented in Table 3 . Table 3 Transplantation outcomes Parameter Total(n = 18) Sex, n (%) Male 11(61) Female 7(39) Disease status before transplantation, n (%) CR 9(50) PR and below 9(50) Median number of infused CD34 + cells (x10 6 /kg) 3.41(2-6.25) Time of neutrophil engraftment 11(9–14) Time of platelet engraftment 14(10–20) Abbreviations: CR, Complete Remission,;PR ,Partial Remission; Adverse Reactions Adverse reactions were assessed using the CTCAE 5.0 grading system. Overall, the total incidence of adverse reactions was 44%, with no grade 3 and above adverse reactions or deaths occurred during the mobilization period. The most common adverse reactions were bone pain (11%), nausea and vomiting (11%), and diarrhea (11%). Other common adverse reactions included anorexia and fatigue (6%),, and headache (6%)(Table 4 ). Table 4 Safety and toxicity TEAEs Any grade Grade 3 and above Total, %(n) 44(8/18) 0 Nausea and Vomiting, %(n) 11(2/18) 0 Diarrhea, %(n) 11(2/18) 0 Anorexia and Fatigue, %(n) 6(1/18) 0 Headache 6(1/18) 0 Rash 0 0 Bone pain 11(2/18) 0 Comparison of Healthcare Resource Utilization In this study, patients with PEGylated rhG-CSF + plerixafor mobilization received an average of 1.83 (± 0.37) injections of rhG-CSF per person. Additionally, the average number of apheresis sessions required to achieve successful collection was 1.33 (± 0.33). The proportion of patients requiring more than 2 days of apheresis was only 5.56%. Furthermore, 5.56% of patients required a second mobilization. Detailed data is presented in Table 5. Table 5. Healthcare resource utilization of patients receiving plerixafor + PEGylated rhG-CSF Indicators Plerixafor + PEGylated rhG-CSF (n = 18) Average G-CSF injections per patient 1.83(±0.37) Average number of collections reaching 2 × 10 6 /kg CD34 + cells 1.33(±0.33) Proportion of patients requiring collection over 2 days 5.56% The proportion of patients required remobilization 5.56% Discussion Hematopoietic stem cell mobilization is crucial for the success of auto-HSCT. Factors such as insufficient CD34 + cell counts after mobilization, difficulty in determining the optimal collection time, and increased number of collections are common challenges faced during the collection process. Plerixafor is a CXCR4 antagonist that promotes the release of stem cells from the bone marrow into the PB and has been recommended for upfront use to obtain the highest CD34 + cell yield in the fewest days of apheresis [ 10 ]. Despite this, studies have reported that 15%-35% of patients are unable to collect the optimal number of stem cells even after up to eight injections of rhG-CSF, four injections of plerixafor, and four stem cell collection [ 6 , 13 , 14 ]. Therefore, there is still a need to explore faster, more efficient, and better-tolerated mobilization protocols in clinical practice [ 15 ]. While previous studies have examined the performance of pegfilgrastim (another long-acting rhG-CSF formulation with a similar mechanism to PEGylated rhG-CSF) combined with plerixafor for mobilization [ 8 , 9 ], our current research represents the first report, to our knowledge, on the efficacy and safety of plerixafor combined with PEGylated rhG-CSF for autologous hematopoietic stem cell (auto-HSC) mobilization in Chinese patients with multiple myeloma (MM). Other trials and retrospective analyses have indicated that pegfilgrastim is at least as effective as filgrastim (one kind of rhG-CSF) in either growth factor-only auto-HSC mobilization [ 8 ] or in the context of chemotherapy mobilization [ 16 ]. Our study differs from some other PEGylated rhG-CSF-containing mobilization studies in that we strictly used growth factors and plerixafor for mobilization, instead of chemotherapy mobilization as reported in previous studies [ 17 , 18 ]. In our study, 100% of patients with PEGylated rhG-CSF + plerixafor achieved the mobilization target and successful collection. The one-day collection success rate was 72%, the overall excellent collection rate was 56%, and the one-day excellent collection rate was 27%. The median CD34 + cell collection was 5.62(2-16.19)×10 6 /kg, and the median CD34 + cell collection on the first day was 3.21(0.61–7.75)×10 6 /kg. Compared to other mobilization protocols reported in the literature, such as rhG-CSF with a success rate of 50–60% [ 6 , 14 , 19 ], the PEGylated rhG-CSF + plerixafor protocol demonstrated a clear advantage in terms of mobilization success rate. Previous literature has reported success rates of 85.4%-95% for mobilization with PEGylated rhG-CSF + plerixafor [ 9 , 20 ], which is consistent with the results of this study. These results indicate that the PEGylated rhG-CSF + plerixafor protocol is effective for stem cell mobilization and significantly better than rhG-CSF or chemotherapy + rhG-CSF. It is noteworthy to mention that in our investigation, two patients exhibited favorable therapeutic outcomes. Case 1 involved a 34-year-old male individual diagnosed with high-risk multiple myeloma (MM). Following initial chemotherapy, the patient attained partial remission (PR). Subsequently, he underwent his first hematopoietic stem cell transplant, but unfortunately, the disease relapsed six months after transplantation. Following a second achievement of PR through treatment, a salvage transplant was devised. In this instance, we utilized a mobilization strategy incorporating PEGylated rhG-CSF and plerixafor. Over a span of two days, an impressive total of 3.61×10 6 /kg CD34 + cells were harvested, ultimately resulting in a successful salvage transplant. Case 2 was a 57-year-old male patient with MM, after achieving complete remission (CR) with induction therapy, failed to mobilize with chemotherapy + rhG-CSF. The patient opted to continue chemotherapy for two years. After two years, the patient agreed to attempt mobilization again with PEGylated rhG-CSF + plerixafor. Over two days, a total of 2.11×10 6 /kg CD34 + cells were collected, resulting in successful stem cell mobilization. Despite the limited number of cases, the successful mobilization achieved in these two patients, who were at a high risk of mobilization failure, provides compelling evidence of the effectiveness of the PEGylated rhG-CSF and plerixafor combination for stem cell mobilization. Among the 16 MM patients who underwent stem cell mobilization and collection, all of them had received hematopoietic stem cell transplantation as of the follow-up time, with no transplant-related deaths. All patients achieved hematopoietic reconstitution. The median time to granulocyte engraftment was 11 (9–14) days, and the median time to megakaryocyte engraftment was 14 (10–20) days, which is similar to previous research findings. In addition, Crees ZD et al . [ 21 ] indicated that stem cells mobilized by CXCR-4 receptor inhibitors in combination with rhG-CSF contain a higher number of immunophenotypically and transcriptionally primitive HSPCs, including multipotent progenitors and common myeloid progenitors (MPPs/CMPs). This could be particularly advantageous for gene editing therapies based on HSPCs, as the long-term efficacy of these therapies depends on the modified HSPCs' ability to establish a stable and long-term engraftment. In this study, no grade 3 or above adverse reactions or deaths occurred during the mobilization process. According to literature reports, the adverse reactions associated with the use of plerixafor are all grade 1 or 2, with the most common grade 1 adverse reactions being gastrointestinal toxicity and bradycardia, accounting for approximately 30% [ 22 – 25 ]. Based on the CTCAE 5.0 criteria, 8 out of 18 patients (44%) who received the PEGylated rhG-CSF + plerixafor mobilization regimen in this study experienced drug-related adverse reactions. The most common adverse reactions were bone pain (11%), nausea and vomiting (11%), and diarrhea (11%), which were all assessed as grade 1–2. These adverse reactions were similar to those reported in the literature and resolved spontaneously after a period of drug discontinuation. The above results indicate that the PEGylated rhG-CSF + plerixafor mobilization regimen is safe and reliable in our study. In terms of healthcare resource utilization, the use of rhG-CSF requires multiple daily injections, causing discomfort and inconvenience for both patients and healthcare professionals. The results in this study including the dosage of rhG-CSF and the number of required collection days, were fewer compared to those reported in previous literature using chemotherapy + rhG-CSF, rhG-CSF alone or plerixafor + rhG-CSF regimens. These findings indicate that the use of PEGylated rhG-CSF + plerixafor results in a significant reduction in healthcare resource utilization, including the number of rhG-CSF injections, apheresis sessions, and the need for second mobilization, compared to the chemotherapy + rhG-CSF. This alleviated patient discomfort and burden, and conserved valuable medical resources. Our study is the first to demonstrate that, in Chinese patients with MM, the combination of PEGylated rhG-CSF and plerixafor exhibits high mobilization success rates and safety for auto-HSC mobilization and collection. Based on these findings, this regimen can be considered a viable and effective option for stem cell mobilization in patients with MM. This study has limitations, including its retrospective design and small sample size. However, the 100% success rate and favorable safety profile provide preliminary evidence supporting the regimen’s utility. Larger prospective trials are warranted to confirm these findings and refine dosing strategies Declarations Funding This research was funded by the scientific research project of the Traditional Chinese Medicine Bureau of Guangdong Province (Grant No. 20241051). Data availability The data presented in this study can be made available, on request, by the corresponding author. Conflict of interest The authors declare that the research was con- ducted without any commercial or financial relationships that could be construed as a potential conflict of interest. Ethical approval This study has been approved by the Fifth Affiliated Hospital of Sun Yat-sen University(Ethics Approval Number: SY5H [2025] Ethical Review (k89-1)). Clinical trial number: not applicable Informed consent Informed consent was obtained from all individual participants included in the study. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adapta- tion, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ . Author Contribution Conceptualization, J.Z. and W.P.; methodology, L.Z. and N.C.; soft- ware,Z.M. and J.Z.; validation, H.Y. and Z.L.; data curation, B.L.;M.C.and F.X.; cell counting,R.H. and P.L.; writing—original draft preparation, J.Z.; Z.M.; B.H.; writing—review and editing, M.T.; supervision, M.T.; funding acquisition, W.P. Data Availability The data that support the findings of this study are available from the authors but restrictions apply to the availability of these data, which were used under license from the Fifth Affiliated Hospital of Sun Yat-sen University for the current study, and so are not publicly available. Data are, however, available from the authors upon reasonable request and with permission from the Fifth Affiliated Hospital of Sun Yat-sen University. References Child JA, Morgan GJ, Davies FE, Owen RG, Bell SE, Hawkins K, et al. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. 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University","correspondingAuthor":false,"prefix":"","firstName":"Zhenting","middleName":"","lastName":"Ma","suffix":""},{"id":454941733,"identity":"3e5faf4c-4e0e-4832-9be5-360195144802","order_by":2,"name":"Bingqi Hou","email":"","orcid":"","institution":"Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Bingqi","middleName":"","lastName":"Hou","suffix":""},{"id":454941734,"identity":"52428758-5131-4537-bdc3-837c77bf733a","order_by":3,"name":"Linjuan Zeng","email":"","orcid":"","institution":"Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Linjuan","middleName":"","lastName":"Zeng","suffix":""},{"id":454941735,"identity":"79796b3d-aa0d-48d4-9635-7f9ae7f76c5c","order_by":4,"name":"Bixiang Li","email":"","orcid":"","institution":"Sun Yat-sen 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University","correspondingAuthor":false,"prefix":"","firstName":"Rijiao","middleName":"","lastName":"Huang","suffix":""},{"id":454941739,"identity":"81844365-778d-4706-a927-bad46e13efd2","order_by":8,"name":"Nan Chen","email":"","orcid":"","institution":"Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Nan","middleName":"","lastName":"Chen","suffix":""},{"id":454941740,"identity":"23d1e5ed-70f5-4627-b563-66e6e52c3467","order_by":9,"name":"Honghui Ye","email":"","orcid":"","institution":"Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Honghui","middleName":"","lastName":"Ye","suffix":""},{"id":454941741,"identity":"e086748d-0c2a-4a9b-a56b-0f4f400cf538","order_by":10,"name":"Zhitao Li","email":"","orcid":"","institution":"Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Zhitao","middleName":"","lastName":"Li","suffix":""},{"id":454941742,"identity":"fc1d2918-8821-41d2-8bdd-ffe9f67e53ec","order_by":11,"name":"Feng Xie","email":"","orcid":"","institution":"Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Feng","middleName":"","lastName":"Xie","suffix":""},{"id":454941743,"identity":"2f3ef03e-2a27-4305-908c-bd9b6bcddad9","order_by":12,"name":"Meiwen Tang","email":"","orcid":"","institution":"Sun Yat-sen University","correspondingAuthor":false,"prefix":"","firstName":"Meiwen","middleName":"","lastName":"Tang","suffix":""},{"id":454941744,"identity":"efd25c83-925d-4761-ae7f-72d57d62cd52","order_by":13,"name":"Wenzheng Pang","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA80lEQVRIiWNgGAWjYLACxgYbBgZm5gYY34AYLWlALYykaTkMJonTYi6RfOzhzx3no/nbGRsYf7bVJTawN2+TYKi5g1OL5Yy0dAPJM7dzZxxmbGDmbTuc2MBzrEyC4dgznFoMbueYSRi23c5tAGlhbDuQ2CABFIE4FZeW/G8SiW3ncucfhjlM/g0hLTlsEgfbDuRuAGph4G1jBtrCg1+L5fxnZpKNbcm5G4FaDvOcO2zcxpNWbJFwDLcWc57DzyR/ttnlzjt/+ODDH2V1sv3shzfe+FCDx2HInAOMbAwMbCBWAk4NGLH2B4/SUTAKRsEoGLEAALWAWJPcCaf7AAAAAElFTkSuQmCC","orcid":"","institution":"Sun Yat-sen University","correspondingAuthor":true,"prefix":"","firstName":"Wenzheng","middleName":"","lastName":"Pang","suffix":""}],"badges":[],"createdAt":"2025-03-19 12:23:28","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6261556/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6261556/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":83534181,"identity":"65666927-48cc-4f4f-8cff-d0b4275bfbc8","added_by":"auto","created_at":"2025-05-28 06:03:54","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":924886,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6261556/v1/eb66018d-465f-4488-9415-19b285c353d7.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"A Retrospective Analysis of the Effectiveness and Safety of Plerixafor Combined with PEGylated rhG-CSF for Autologous Hematopoietic Stem Cell Mobilization in Patients with Multiple Myeloma","fulltext":[{"header":"Introduction","content":"\u003cp\u003eHigh-dose chemotherapy coupled with autologous peripheral blood (PB) hematopoietic stem cell transplantation serves as a pivotal therapeutic modality for hematopoietic system tumors and has become the standard first-line treatment for multiple myeloma (MM), significantly prolonging patient survival and improving prognosis [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Ensuring an adequate yield of hematopoietic stem cells (HSCs) is critical for successful transplantation. Current mobilization strategies include granulocyte colony-stimulating factor (rhG-CSF) alone, chemotherapy combined with rhG-CSF, and plerixafor paired with rhG-CSF. While rhG-CSF remains the standard agent for PB HSC mobilization, the addition of chemotherapy may enhance mobilization efficacy but introduces prolonged timelines, multiple apheresis sessions, and chemotherapy-related toxicities [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. These drawbacks amplify healthcare costs and logistical burdens [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eA pivotal phase III trial (DiPersio et al. 2009) established the efficacy of plerixafor\u0026thinsp;+\u0026thinsp;rhG-CSF for first-line steady-state mobilization in MM patients, demonstrating superior CD34\u0026thinsp;+\u0026thinsp;cell yields compared to rhG-CSF alone [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Subsequent post hoc analyses and observational studies further supported its utility in reducing apheresis days and improving mobilization success rates [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. However, rhG-CSF requires daily injections, posing practical challenges for patients and healthcare providers. In contrast, PEGylated rhG-CSF-a long-acting formulation with an extended half-life\u0026mdash;enables sustained mobilization via a single injection, simplifying administration and aligning with resource-constrained clinical settings [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Emerging evidence suggests that combining PEGylated rhG-CSF with plerixafor may optimize mobilization efficiency while minimizing burdensome protocols [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn China, challenges such as limited access to repeated apheresis and patient preference for fewer injections motivated the upfront use of PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor, even in patients without prior mobilization failure. This strategy aligns with global trends favoring fixed-day protocols to reduce healthcare resource utilization [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Early adoption of this combination may also preempt mobilization failure in high-risk MM populations, such as elderly patients or those with extensive prior therapy.\u003c/p\u003e \u003cp\u003eDespite promising data from Western cohorts, evidence for PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor in Chinese MM patients remains scarce. This study aims to address this gap by evaluating the efficacy and safety of this regimen in a Chinese clinical context.\u003c/p\u003e"},{"header":"Patients and methods","content":"\u003cp\u003eBetween December 2021 and June 2024, a total of 20 patients with multiple myeloma (MM) underwent autologous peripheral blood (PB) hematopoietic stem cell mobilization at the Fifth Affiliated Hospital of Sun Yat-sen University, utilizing a regimen of PEGylated rhG-CSF (CSPC Pharmaceutical Group Co., Ltd., Yantai, China) combined with plerixafor (Yifan Biopharmaceutical Co., Ltd., Hefei, China). The diagnosis of MM was confirmed based on a comprehensive evaluation encompassing bone marrow morphology, immunology, cytogenetics, molecular biology, as well as imaging modalities such as enhanced computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET-CT). This study was conducted in accordance with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the Fifth Affiliated Hospital of Sun Yat-sen University (No. SY5H [2025] Ethical Review (k89-1)).\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eTreatment\u003c/h2\u003e \u003cp\u003e Referring to domestic and international treatment guidelines for MM, induction therapy typically employs a bortezomib-based three-drug combination regimen, such as VRd, DPd, VCD, etc. Considering the disease subtype, stage, and molecular biology characteristics of the patient, auto-HSC mobilization and collection are typically performed after approximately four courses of treatment, contingent upon the patient's remission status.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eMobilization and Collection Protocol\u003c/h3\u003e\n\u003cdiv class=\"Heading\"\u003eMobilization and Collection Protocol\u003c/div\u003e \u003cp\u003ePEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;Plerixafor mobilization protocol: ①PEG-rhG-CSF 12mg subcutaneous injection on Day 1, and rhG-CSF 10 \u0026micro;g\u0026middot;kg\u003csup\u003e\u0026minus;\u0026thinsp;1\u003c/sup\u003e\u0026middot;d\u003csup\u003e\u0026minus;\u0026thinsp;1\u003c/sup\u003e administered at 6:00 AM on the day of collection, for a maximum of 3 consecutive days. ②Plerixafor 1.2 ml (2.4mg), subcutaneous injection at 22:00 on Day 4. ③PB hematopoietic stem cell collection using blood cell separator (Spectra Optia,Terumo BCT, Inc.,Japan) begins at 9:00 on Day 5, accompanied by CD34\u0026thinsp;+\u0026thinsp;cell which are measured by flow cytometry (Beckman Coulter, Beckman Coulter Biotechnology (Suzhou) Co., Ltd., China) and mononuclear cell (MNC) counting.\u003c/p\u003e \u003cp\u003eThe target for auto-HSC collection is CD34\u0026thinsp;+\u0026thinsp;cells\u0026thinsp;\u0026ge;\u0026thinsp;2.0\u0026times;10\u003csup\u003e6\u003c/sup\u003e/kg. Successful collection is defined as CD34\u0026thinsp;+\u0026thinsp;cells\u0026thinsp;\u0026ge;\u0026thinsp;2.0\u0026times;10\u003csup\u003e6\u003c/sup\u003e/kg, and the excellent collection is CD34\u0026thinsp;+\u0026thinsp;cells\u0026thinsp;\u0026ge;\u0026thinsp;5.0\u0026times;10\u003csup\u003e6\u003c/sup\u003e/kg. For this analysis, we defined mobilization failure as a cumulative yield of CD34\u0026thinsp;+\u0026thinsp;cells\u0026thinsp;\u0026lt;\u0026thinsp;2.0\u0026times;10\u003csup\u003e6\u003c/sup\u003e/kg, the minimum cell dose considered acceptable for once transplantation [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e\n\u003ch3\u003ePretreatment protocol and engraftment criteria for auto-HSCT\u003c/h3\u003e\n\u003cp\u003eMM pretreatment regimen: Melphalan 200mg/m\u003csup\u003e2\u003c/sup\u003e (if creatinine clearance is \u0026lt;\u0026thinsp;60%, the dose is reduced to 140mg/m\u003csup\u003e2\u003c/sup\u003e), administered over 2 days, starting on day \u0026minus;\u0026thinsp;3. rhG-CSF 5ug\u0026middot;kg\u003csup\u003e\u0026minus;\u0026thinsp;1\u003c/sup\u003e\u0026middot;d\u003csup\u003e\u0026minus;\u0026thinsp;1\u003c/sup\u003e is given from day\u0026thinsp;+\u0026thinsp;3 until granulocyte reconstitution.\u003c/p\u003e \u003cp\u003eImplantation criteria: Neutrophil engraftment is defined as an absolute neutrophil count (ANC)\u0026thinsp;\u0026ge;\u0026thinsp;0.5 \u0026times; 10\u003csup\u003e9\u003c/sup\u003e/L for 3 consecutive days; platelet engraftment is defined as a platelet count (PLT)\u0026thinsp;\u0026ge;\u0026thinsp;20.0 \u0026times; 10\u003csup\u003e9\u003c/sup\u003e/L for 7 consecutive days and independence from platelet transfusion.\u003c/p\u003e\n\u003ch3\u003eDefinitions, Efficacy Evaluation Criteria, and Safety Assessment\u003c/h3\u003e\n\u003cp\u003eThe efficacy evaluation of MM was previously described in detail [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], and adverse reactions are graded according to the CTCAE version 5.0 classification standard.\u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eDescriptive statistical analysis was performed using SPSS 26.0 software. Numerical variables were described as means (\u0026plusmn;\u0026thinsp;standard deviation). Skewed numerical variables were described as medians (ranges).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n \u003ch2\u003eClinical Characteristics\u003c/h2\u003e\n \u003cp\u003eA total of 18 MM patients underwent mobilization with PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor. Their median age was 59 years old (range: 35\u0026ndash;66 years old), including 11 males and 7 females. Before mobilization, the median number of chemotherapy cycles received by these patients was 4, with a range from 3 to 19 cycles. Among these patients, 12 had undergone\u0026thinsp;\u0026le;\u0026thinsp;4 cycles of chemotherapy before mobilization. Three patients had a history of previous chemotherapy combined with rhG-CSF mobilization. Of these three, two patients failed to achieve successful mobilization, while the third patient had successful mobilization but later experienced disease relapse. They were re-mobilized with PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor before undergoing salvage transplantation. The median time from diagnosis to mobilization was 4.5 months (range: 3\u0026ndash;39 months). The general characteristics of all patients are shown in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eClinical Characteristics\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eCharacteristics\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eMM\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eNumber\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e18\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMedian age (range), years\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e59(35\u0026ndash;66)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e11(61)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7(39)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMedian no. of induction cycles(range)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4(3\u0026ndash;19)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eNo. of induction cycles, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026le;4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e12(67)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026gt;4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6(33)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMedian cycles of lenalidomide (range)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4(0\u0026ndash;6)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMobilizer status, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e8(44)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e8(44)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2(11)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003ePrevious chemotherapy mobilization, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3(17)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMedian time from diagnosis to consent, months\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4.5(3\u0026ndash;39)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003eResults of auto-HSC Collection\u003c/h3\u003e\n\u003cp\u003eThe overall success rate of stem cell collection was 100%, with a 1-day collection success rate of 72% and a 2-day collection success rate of 94%. The overall collection excellence rate was 56%, and the 1-day collection excellence rate was 27%. The median CD34\u0026thinsp;+\u0026thinsp;yield of all patients was 5.62 (2-16.19) \u0026times; 10\u003csup\u003e6\u003c/sup\u003e/kg, and the median CD34\u0026thinsp;+\u0026thinsp;yield on first day of collection was 3.21 (0.61\u0026ndash;7.75) \u0026times; 10\u003csup\u003e6\u003c/sup\u003e/kg. Median CD34\u0026thinsp;+\u0026thinsp;number in PB on first day of collection was 78 (5-188) cells/\u0026micro;l. Detailed data is presented in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eResults of auto-HSC Collection\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eOutcome\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eMM (n\u0026thinsp;=\u0026thinsp;18)\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatients reaching ⩾ 2 \u0026times; 106/kg CD34\u0026thinsp;+\u0026thinsp;cells, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e18(100)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatients reaching ⩾ 2 \u0026times; 106/kg CD34\u0026thinsp;+\u0026thinsp;cells in 1 collection, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e13(72)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatients reaching ⩾ 2 \u0026times; 106/kg CD34\u0026thinsp;+\u0026thinsp;cells in 2 collection,n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e17(94)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatients reaching ⩾ 5 \u0026times; 106/kg CD34\u0026thinsp;+\u0026thinsp;cells,n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10(56)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatients reaching ⩾ 5 \u0026times; 106/kg CD34\u0026thinsp;+\u0026thinsp;cells in 1 collection,n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5(27)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePatients reaching ⩾ 5 \u0026times; 106/kg CD34\u0026thinsp;+\u0026thinsp;cells in 2 collection,n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10(56)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCumulative CD34\u0026thinsp;+\u0026thinsp;cell yield, \u0026times;106/kg, median (range)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5.62(2-16.19)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCD34\u0026thinsp;+\u0026thinsp;yield on first day of collection, \u0026times;106/kg, median (range)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3.21(0.61\u0026ndash;7.75)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCD34\u0026thinsp;+\u0026thinsp;cells/uL in PB on first day of collection, median (range)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e78(5-188)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003eTransplantation Status and Hematopoietic Reconstitution\u003c/h2\u003e\n \u003cp\u003eAs of now, 18 patients underwent auto-HSCT. The median of CD34\u0026thinsp;+\u0026thinsp;HSPCs infused for auto-HSCT was 3.41 (2-6.25)\u0026times;10\u003csup\u003e6\u003c/sup\u003e/kg. The neutrophil engraftment time was 11 (9\u0026ndash;14) days, and the platelet engraftment time was 14 (10\u0026ndash;20) days. The time to hematopoietic reconstitution were consistent with contemporary outcomes. Information on transplantation status and hematopoietic reconstitution is presented in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab3\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eTransplantation outcomes\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eParameter\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eTotal(n\u0026thinsp;=\u0026thinsp;18)\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eSex, n (%)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e11(61)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7(39)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eDisease status before transplantation, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCR\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e9(50)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePR and below\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e9(50)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMedian number of infused CD34\u0026thinsp;+\u0026thinsp;cells (x10\u003c/strong\u003e\u003csup\u003e\u003cstrong\u003e6\u003c/strong\u003e\u003c/sup\u003e\u003cstrong\u003e/kg)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3.41(2-6.25)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eTime of neutrophil engraftment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e11(9\u0026ndash;14)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eTime of platelet engraftment\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e14(10\u0026ndash;20)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" colspan=\"2\"\u003e\n \u003cp\u003eAbbreviations: CR, Complete Remission,;PR ,Partial Remission;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\n \u003ch2\u003eAdverse Reactions\u003c/h2\u003e\n \u003cp\u003eAdverse reactions were assessed using the CTCAE 5.0 grading system. Overall, the total incidence of adverse reactions was 44%, with no grade 3 and above adverse reactions or deaths occurred during the mobilization period. The most common adverse reactions were bone pain (11%), nausea and vomiting (11%), and diarrhea (11%). Other common adverse reactions included anorexia and fatigue (6%),, and headache (6%)(Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e).\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Tab4\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\n \u003cdiv class=\"CaptionContent\"\u003e\n \u003cp\u003eSafety and toxicity\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eTEAEs\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eAny grade\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eGrade 3 and above\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTotal, %(n)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e44(8/18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNausea and Vomiting, %(n)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e11(2/18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eDiarrhea, %(n)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e11(2/18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAnorexia and Fatigue, %(n)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6(1/18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eHeadache\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6(1/18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRash\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eBone pain\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e11(2/18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\n \u003ch2\u003eComparison of Healthcare Resource Utilization\u003c/h2\u003e\n \u003cp\u003eIn this study, patients with PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor mobilization received an average of 1.83 (\u0026plusmn;\u0026thinsp;0.37) injections of rhG-CSF per person. Additionally, the average number of apheresis sessions required to achieve successful collection was 1.33 (\u0026plusmn;\u0026thinsp;0.33). The proportion of patients requiring more than 2 days of apheresis was only 5.56%. Furthermore, 5.56% of patients required a second mobilization. Detailed data is presented in Table 5.\u003c/p\u003e\n \u003cp\u003e\u003cbr\u003eTable 5. Healthcare resource utilization of patients receiving plerixafor\u0026thinsp;+\u0026thinsp;PEGylated rhG-CSF\u003c/p\u003e\n \u003cdiv class=\"gridtable\"\u003e\u0026nbsp;\u003ctable id=\"Taba\" border=\"1\" style=\"margin-right: calc(20%); width: 80%;\"\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\" style=\"width: 59.4556%;\"\u003e\n \u003cp\u003eIndicators\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" style=\"width: 40.5444%;\"\u003e\n \u003cp\u003ePlerixafor\u0026thinsp;+\u0026thinsp;PEGylated rhG-CSF (n\u0026thinsp;=\u0026thinsp;18)\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" style=\"width: 59.4556%;\"\u003e\n \u003cp\u003eAverage G-CSF injections per patient\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 40.5444%;\"\u003e\n \u003cp\u003e1.83(\u0026plusmn;0.37)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" style=\"width: 59.4556%;\"\u003e\n \u003cp\u003eAverage number of collections reaching 2 \u0026times; 10\u003csup\u003e6\u003c/sup\u003e/kg CD34\u0026thinsp;+\u0026thinsp;cells\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 40.5444%;\"\u003e\n \u003cp\u003e1.33(\u0026plusmn;0.33)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" style=\"width: 59.4556%;\"\u003e\n \u003cp\u003eProportion of patients requiring collection over 2 days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 40.5444%;\"\u003e\n \u003cp\u003e5.56%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\" style=\"width: 59.4556%;\"\u003e\n \u003cp\u003eThe proportion of patients required remobilization\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\" style=\"width: 40.5444%;\"\u003e\n \u003cp\u003e5.56%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cbr\u003e\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eHematopoietic stem cell mobilization is crucial for the success of auto-HSCT. Factors such as insufficient CD34\u0026thinsp;+\u0026thinsp;cell counts after mobilization, difficulty in determining the optimal collection time, and increased number of collections are common challenges faced during the collection process. Plerixafor is a CXCR4 antagonist that promotes the release of stem cells from the bone marrow into the PB and has been recommended for upfront use to obtain the highest CD34\u0026thinsp;+\u0026thinsp;cell yield in the fewest days of apheresis [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Despite this, studies have reported that 15%-35% of patients are unable to collect the optimal number of stem cells even after up to eight injections of rhG-CSF, four injections of plerixafor, and four stem cell collection [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Therefore, there is still a need to explore faster, more efficient, and better-tolerated mobilization protocols in clinical practice [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. While previous studies have examined the performance of pegfilgrastim (another long-acting rhG-CSF formulation with a similar mechanism to PEGylated rhG-CSF) combined with plerixafor for mobilization [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e], our current research represents the first report, to our knowledge, on the efficacy and safety of plerixafor combined with PEGylated rhG-CSF for autologous hematopoietic stem cell (auto-HSC) mobilization in Chinese patients with multiple myeloma (MM).\u003c/p\u003e \u003cp\u003eOther trials and retrospective analyses have indicated that pegfilgrastim is at least as effective as filgrastim (one kind of rhG-CSF) in either growth factor-only auto-HSC mobilization [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] or in the context of chemotherapy mobilization [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Our study differs from some other PEGylated rhG-CSF-containing mobilization studies in that we strictly used growth factors and plerixafor for mobilization, instead of chemotherapy mobilization as reported in previous studies [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. In our study, 100% of patients with PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor achieved the mobilization target and successful collection. The one-day collection success rate was 72%, the overall excellent collection rate was 56%, and the one-day excellent collection rate was 27%. The median CD34\u0026thinsp;+\u0026thinsp;cell collection was 5.62(2-16.19)\u0026times;10\u003csup\u003e6\u003c/sup\u003e/kg, and the median CD34\u0026thinsp;+\u0026thinsp;cell collection on the first day was 3.21(0.61\u0026ndash;7.75)\u0026times;10\u003csup\u003e6\u003c/sup\u003e/kg. Compared to other mobilization protocols reported in the literature, such as rhG-CSF with a success rate of 50\u0026ndash;60% [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e], the PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor protocol demonstrated a clear advantage in terms of mobilization success rate. Previous literature has reported success rates of 85.4%-95% for mobilization with PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e], which is consistent with the results of this study. These results indicate that the PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor protocol is effective for stem cell mobilization and significantly better than rhG-CSF or chemotherapy\u0026thinsp;+\u0026thinsp;rhG-CSF.\u003c/p\u003e \u003cp\u003eIt is noteworthy to mention that in our investigation, two patients exhibited favorable therapeutic outcomes. Case 1 involved a 34-year-old male individual diagnosed with high-risk multiple myeloma (MM). Following initial chemotherapy, the patient attained partial remission (PR). Subsequently, he underwent his first hematopoietic stem cell transplant, but unfortunately, the disease relapsed six months after transplantation. Following a second achievement of PR through treatment, a salvage transplant was devised. In this instance, we utilized a mobilization strategy incorporating PEGylated rhG-CSF and plerixafor. Over a span of two days, an impressive total of 3.61\u0026times;10\u003csup\u003e6\u003c/sup\u003e/kg CD34\u0026thinsp;+\u0026thinsp;cells were harvested, ultimately resulting in a successful salvage transplant. Case 2 was a 57-year-old male patient with MM, after achieving complete remission (CR) with induction therapy, failed to mobilize with chemotherapy\u0026thinsp;+\u0026thinsp;rhG-CSF. The patient opted to continue chemotherapy for two years. After two years, the patient agreed to attempt mobilization again with PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor. Over two days, a total of 2.11\u0026times;10\u003csup\u003e6\u003c/sup\u003e/kg CD34\u0026thinsp;+\u0026thinsp;cells were collected, resulting in successful stem cell mobilization. Despite the limited number of cases, the successful mobilization achieved in these two patients, who were at a high risk of mobilization failure, provides compelling evidence of the effectiveness of the PEGylated rhG-CSF and plerixafor combination for stem cell mobilization.\u003c/p\u003e \u003cp\u003eAmong the 16 MM patients who underwent stem cell mobilization and collection, all of them had received hematopoietic stem cell transplantation as of the follow-up time, with no transplant-related deaths. All patients achieved hematopoietic reconstitution. The median time to granulocyte engraftment was 11 (9\u0026ndash;14) days, and the median time to megakaryocyte engraftment was 14 (10\u0026ndash;20) days, which is similar to previous research findings.\u003c/p\u003e \u003cp\u003eIn addition, Crees ZD \u003cem\u003eet al\u003c/em\u003e. [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e] indicated that stem cells mobilized by CXCR-4 receptor inhibitors in combination with rhG-CSF contain a higher number of immunophenotypically and transcriptionally primitive HSPCs, including multipotent progenitors and common myeloid progenitors (MPPs/CMPs). This could be particularly advantageous for gene editing therapies based on HSPCs, as the long-term efficacy of these therapies depends on the modified HSPCs' ability to establish a stable and long-term engraftment.\u003c/p\u003e \u003cp\u003eIn this study, no grade 3 or above adverse reactions or deaths occurred during the mobilization process. According to literature reports, the adverse reactions associated with the use of plerixafor are all grade 1 or 2, with the most common grade 1 adverse reactions being gastrointestinal toxicity and bradycardia, accounting for approximately 30% [\u003cspan additionalcitationids=\"CR23 CR24\" citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Based on the CTCAE 5.0 criteria, 8 out of 18 patients (44%) who received the PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor mobilization regimen in this study experienced drug-related adverse reactions. The most common adverse reactions were bone pain (11%), nausea and vomiting (11%), and diarrhea (11%), which were all assessed as grade 1\u0026ndash;2. These adverse reactions were similar to those reported in the literature and resolved spontaneously after a period of drug discontinuation. The above results indicate that the PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor mobilization regimen is safe and reliable in our study.\u003c/p\u003e \u003cp\u003eIn terms of healthcare resource utilization, the use of rhG-CSF requires multiple daily injections, causing discomfort and inconvenience for both patients and healthcare professionals. The results in this study including the dosage of rhG-CSF and the number of required collection days, were fewer compared to those reported in previous literature using chemotherapy\u0026thinsp;+\u0026thinsp;rhG-CSF, rhG-CSF alone or plerixafor\u0026thinsp;+\u0026thinsp;rhG-CSF regimens. These findings indicate that the use of PEGylated rhG-CSF\u0026thinsp;+\u0026thinsp;plerixafor results in a significant reduction in healthcare resource utilization, including the number of rhG-CSF injections, apheresis sessions, and the need for second mobilization, compared to the chemotherapy\u0026thinsp;+\u0026thinsp;rhG-CSF. This alleviated patient discomfort and burden, and conserved valuable medical resources.\u003c/p\u003e \u003cp\u003eOur study is the first to demonstrate that, in Chinese patients with MM, the combination of PEGylated rhG-CSF and plerixafor exhibits high mobilization success rates and safety for auto-HSC mobilization and collection. Based on these findings, this regimen can be considered a viable and effective option for stem cell mobilization in patients with MM.\u003c/p\u003e \u003cp\u003eThis study has limitations, including its retrospective design and small sample size. However, the 100% success rate and favorable safety profile provide preliminary evidence supporting the regimen\u0026rsquo;s utility. Larger prospective trials are warranted to confirm these findings and refine dosing strategies\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eFunding\u003c/h2\u003e \u003cp\u003eThis research was funded by the scientific research project of the Traditional Chinese Medicine Bureau of Guangdong Province (Grant No. 20241051).\u003c/p\u003e \u003cp\u003e \u003cb\u003eData availability\u003c/b\u003e The data presented in this study can be made available, on request, by the corresponding author.\u003c/p\u003e \u003cp\u003e \u003cb\u003eConflict of interest\u003c/b\u003e The authors declare that the research was con- ducted without any commercial or financial relationships that could be construed as a potential conflict of interest.\u003c/p\u003e \u003cp\u003e\u003cb\u003eEthical approval\u003c/b\u003e This study has been approved by the Fifth Affiliated Hospital of Sun Yat-sen University(Ethics Approval Number: SY5H [2025] Ethical Review (k89-1)).\u003c/p\u003e \u003cp\u003eClinical trial number: not applicable\u003c/p\u003e \u003cp\u003e\u003cb\u003eInformed consent\u003c/b\u003e Informed consent was obtained from all individual participants included in the study.\u003c/p\u003e \u003cp\u003e \u003cb\u003eOpen Access\u003c/b\u003e This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adapta- tion, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttp://creativecommons.org/licenses/by/4.0/\u003c/span\u003e\u003cspan address=\"http://creativecommons.org/licenses/by/4.0/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eConceptualization, J.Z. and W.P.; methodology, L.Z. and N.C.; soft- ware,Z.M. and J.Z.; validation, H.Y. and Z.L.; data curation, B.L.;M.C.and F.X.; cell counting,R.H. and P.L.; writing\u0026mdash;original draft preparation, J.Z.; Z.M.; B.H.; writing\u0026mdash;review and editing, M.T.; supervision, M.T.; funding acquisition, W.P.\u003c/p\u003e\u003ch2\u003eData Availability\u003c/h2\u003e\u003cp\u003eThe data that support the findings of this study are available from the authors but restrictions apply to the availability of these data, which were used under license from the Fifth Affiliated Hospital of Sun Yat-sen University for the current study, and so are not publicly available. Data are, however, available from the authors upon reasonable request and with permission from the Fifth Affiliated Hospital of Sun Yat-sen University.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eChild JA, Morgan GJ, Davies FE, Owen RG, Bell SE, Hawkins K, et al. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med 2003;348(19):1875\u0026ndash;83 doi \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1056/NEJMoa022340\u003c/span\u003e\u003cspan address=\"10.1056/NEJMoa022340\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBaertsch MA, Schlenzka J, Lisenko K, Krzykalla J, Becker N, Weisel K, et al. Cyclophosphamide-based stem cell mobilization in relapsed multiple myeloma patients: A subgroup analysis from the phase III trial ReLApsE. 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Transfusion 2015;55(8):1993\u0026ndash;2000 doi \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1111/trf.13059\u003c/span\u003e\u003cspan address=\"10.1111/trf.13059\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHauge AW, Haastrup EK, Sengelov H, Minulescu L, Dickmeiss E, Fischer-Nielsen A. Addition of plerixafor for CD34\u0026thinsp;+\u0026thinsp;cell mobilization in six healthy stem cell donors ensured satisfactory grafts for transplantation. Transfusion 2014;54(4):1055\u0026ndash;8 doi \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1111/trf.12383\u003c/span\u003e\u003cspan address=\"10.1111/trf.12383\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Plerixafor, PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor, Multiple Myeloma, Autologous hematopoietic stem cell mobilization, Efficacy and Safety","lastPublishedDoi":"10.21203/rs.3.rs-6261556/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6261556/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose \u003c/strong\u003eThe study aims to assess the clinical efficacy and safety profile of plerixafor in combination with polyethylene glycolated recombinant human granulocyte colony-stimulating factor (PEGylated rhG-CSF) for autologous hematopoietic stem cell (auto-HSC) mobilization in\u0026nbsp; patients diagnosed with multiple myeloma (MM).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e A retrospective analysis was conducted to evaluate the stem cell collection efficiency, post-transplant hematopoietic reconstitution, and mobilization-related adverse events in a cohort of 18 MM patients who underwent stem cell mobilization using the combination of plerixafor and PEGylated rhG-CSF. Successful mobilization was defined as achieving or surpassing a threshold of 2.0×10\u003csup\u003e6\u003c/sup\u003e/kg. An excellent mobilization is characterized by achieving a yield of at least 5.0×10\u003csup\u003e6\u003c/sup\u003e/kg.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults \u003c/strong\u003eOur results revealed an overall stem cell collection success rate of 100%. Notably, 72% of patients achieved successful mobilization within the first day. Furthermore, the overall excellent collection rate was 56%, with a 1-day excellent collection rate of 27%. The median number of collected CD34+ cells was 5.62(2-16.19)×106/kg. The most frequently encountered adverse events were bone pain (11%), nausea and vomiting (11%), and diarrhea (11%), all classified as grade 1-2. All patients underwent auto-HSC transplantation, with a median engraftment time of 11 (ranging from 9 to 14) days for neutrophils and 14 (ranging from 10 to 20) days for platelets, respectively.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e In conclusion, this is the first report of the combination of PEGylated rhG-CSF and plerixafor for auto-HSC mobilization and collection in\u0026nbsp; patients with MM, and the results show good mobilization success rate and safety.\u003c/p\u003e","manuscriptTitle":"A Retrospective Analysis of the Effectiveness and Safety of Plerixafor Combined with PEGylated rhG-CSF for Autologous Hematopoietic Stem Cell Mobilization in Patients with Multiple Myeloma","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-05-14 06:00:38","doi":"10.21203/rs.3.rs-6261556/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"a33c2754-d872-48ad-a188-af13ddc897f6","owner":[],"postedDate":"May 14th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-05-28T05:39:06+00:00","versionOfRecord":[],"versionCreatedAt":"2025-05-14 06:00:38","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6261556","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6261556","identity":"rs-6261556","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}