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Clinical Trial
. 2025 Mar;60(3):270-276.
doi: 10.1038/s41409-024-02468-z. Epub 2024 Nov 15.

Comparing stem cell mobilization with chemotherapy and cytokine (G-CSF) versus cytokine alone in myeloma patients (MOCCCA): a randomized phase II, open-label, non-inferiority trial

Barbara Jeker #  1 , Laura Thalmann #  1 , Ulrike Bacher  2 , Henning Nilius  3 , Gaëlle Rhyner  4 , Martin Sökler  5 , Susanne Soltermann  6 , Annette Winkler  7 , Corinne Vorburger  1 , Michael Daskalakis  2 , Michèle Hoffmann  1 , Thomas Pabst  8
Affiliations
Clinical Trial

Comparing stem cell mobilization with chemotherapy and cytokine (G-CSF) versus cytokine alone in myeloma patients (MOCCCA): a randomized phase II, open-label, non-inferiority trial

Barbara Jeker et al. Bone Marrow Transplant. 2025 Mar.

Abstract

In fit patients with newly diagnosed myeloma, high-dose chemotherapy (HDCT) followed by autologous stem cell transplantation (ASCT) is considered standard of care. For mobilization of CD34+ cells for ASCT, combined cytotoxic chemotherapy and G-CSF is commonly used. However, the importance of cytostatic chemotherapy for reliable mobilization remains unclear. This prospective randomized phase II non-inferiority trial compared G-GSF only (G) compared to standard chemotherapy/G-CSF (CG) for CD34+ mobilization. The primary endpoint was a less than 15% difference in successful stem cell collection ( ≥ 5.0 × 106 CD34+ cells/kg b.w. in a single day collection procedure without additional stimulation with plerixafor) with the G regimen. 136 patients were 1:1 randomized. With an 18% difference in favor of the CG therapy, the non-inferiority margin was not maintained (95% CI 1%, 34%, p = 0.04). The median total CD34+ yield was 9.99 × 106/kg b.w. in CG patients and 7.42 × 106/kg b.w. in patients with G-CSF alone (p < 0.001). Ultimately, 130 (96%) patients proceeded to HDCT with ASCT. There were no differences in adverse events, hematologic engraftment, quality of life, or pain perception between the groups. Our data indicate that G-CSF only is inferior to chemotherapy with G-CSF for peripheral CD34+ stem cell mobilization. Trial registration SNCTP #: SNCTP000002952; Trials.gov #: NCT03442673.

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Conflict of interest statement

Competing interests: MD received financial support for attending haematology meetings from Kite Gilead/Novartis and serves as an advisory board member for Novartis. There are no financial disclosures from any of the other authors. Ethics approval and consent to participate: We confirm that all methods were performed in accordance with the relevant guidelines and regulations. The study had approval by the local Ethics Committee of Bern, Switzerland, with the decision number 2018-00615. Written informed consent was obtained from all participants.

Figures

Fig. 1
Fig. 1. First day of CD34+ apheresis.
CG chemotherapy plus G-CSF group, G G-CSF only group. X = planned apheresis day.
Fig. 2
Fig. 2. Total collected CD34+ cells.
CG chemotherapy plus G-CSF group. G G-CSF only group. Median number of collected CD34+ cells, CG: 9.99 × 106/kg b.w. (median IQR 7.40–13.88); G: 7.42 × 106/kg b.w. (median IQR 5.61–10.56).
Fig. 3
Fig. 3. Pain perception during mobilization treatment.
CG chemotherapy plus G-CSF group. G G-CSF only group, VAS visual analog scale (reaching from 1 to 10 points, 10 being the most painful ranking). Median VAS on first mobilization treatment day, CG: 3 (median IQR 2–4); G: 3 (median IQR 2–5.5). Median VAS on planned first apheresis day, CG: 4 (median IQR 2–5); G: 3 (median IQR 2–5).
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