Plerixafor plus granulocyte-colony stimulating factor (G-CSF) enhances the mobilization of hematopoietic stem cells (HSCs) for collection and subsequent autologous hematopoietic stem cell transplantation (HSCT) in patients with multiple myeloma (MM). This international, multicenter, noninterventional registry study (NCT01362972), evaluated long-term outcomes for MM patients who received plerixafor versus other mobilization regimens. The comparisons were: G-CSF + plerixafor (G-CSF + P) versus G-CSF-; G-CSF + P versus G-CSF + chemotherapy (G-CSF + C); and G-CSF + P + C versus G-CSF + C. Propensity score matching was used to balance groups. Primary outcome measures were progression free survival (PFS), overall survival (OS), and cumulative incidence of relapse (CIR) after transplantation. After propensity matching, 77 versus 41 patients in the G-CSF + P versus G-CSF cohorts, 129 versus 129 in the G-CSF + P versus G-CSF + C cohorts, and 117 versus 117 in the G-CSF + P + C versus G-CSF + C cohorts were matched, respectively. Propensity score matching resulted in a smaller sample size and imbalances were not completely overcome. For both PFS and OS, the upper limits of the hazard ratio 95% confidence intervals exceeded prespecified boundaries; noninferiority was not demonstrated. CIR rates were higher in the plerixafor cohorts. G-CSF + P remains an option for the mobilization of HSCs in poor mobilizers with MM with no substantial differences in PFS, OS, and CIR in comparison with other regimens.

Charles University Hospital Prague Czech Republic

Department of Internal Medicine Hematology and Oncology University Hospital Brno and Faculty of Medicine Masaryk University Brno Czech Republic

European Society for Blood and Marrow Transplantation Leiden The Netherlands

Hospital Saint Antoine Paris France

Imperial College London London UK

Institut Paoli Calmettes Marseille France

Karolinska University Hospital Stockholm Sweden

Medical University of Warsaw Warsaw Poland

Nottingham University Nottingham UK

Queens University Belfast UK

Radboud University Medical Centre Nijmegen The Netherlands

Sanofi Cambridge MA USA

Semmelweis University Budapest Hungary

Skanes University Hospital Lund Sweden

St James Hospital Dublin Ireland

University Hospital Hamburg Germany

University Hospital of Dusseldorf Dusseldorf Germany

University Tor Vergata Rome Italy

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Complications of Autologous Stem Cell Transplantation in Multiple Myeloma: Results from the CALM Study

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ClinicalTrials.gov
NCT01362972