A Phase 2 interventional study of Vinorelbine and Gemcitabine in Multiple Myeloma, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Insel Gruppe AG, University Hospital Bern · Phase 2, Interventional, and Treatment
This study aims to demonstrate that the mobilization with cytokine stimulation with G-CSF alone is non-inferior as compared to the standard mobilization with chemotherapy and G-CSF while associated with fewer side effects in myeloma patients.
Background and Rationale High-dose chemotherapy (HDCT) with melphalan and autologous stem cell transplantation (ASCT) remains an integral component of the myeloma treatment algorithm for patients considered eligible for the procedure, nowadays performed in myeloma patients up to the age of 75 years. Until the advent of the novel agents, the initial therapy regimens commonly used were vincristine, doxorubicin, and dexamethasone (VAD) or single-agent dexamethasone, both of which shared the advantage of having little impact on stem cell mobilization and collection. Previous studies had shown that alkylating agents can potentially affect the stem cell pool and thus interfere with the ability to collect adequate numbers of stem cells. However, VAD is no longer uses nowadays, whereas current lenalidomide-containing combinations significantly affect stem cell collection. .In Switzerland, the combination of non-myeloablative chemotherapy with vinorelbine or gemcitabine and G-CSF is the current standard procedure. With the predominant use of bortezomib during induction treatment more patients have pre-existing neurotoxicity. Vinorelbine can aggravate this problem. Recently data have shown that a mobilization with gemcitabine together with G-CSF is safe and effective in myeloma patients. Whether chemotherapy is mandatory at all to achieve the same reliable and cost-effective mobilization is currently unknown. The investigators therefore consider that a direct comparison between vinorelbine/gemcitabine and G-CSF versus G-CSF alone is justified.
Objective:
The primary objective is to show non-inferiority of cytokine stimulation with G-CSF compared to chemotherapy stimulation with vinorelbine (or gemcitabine) together with G-CSF for the mobilization of autologous stem cells in myeloma patients in first remission.
Study Duration:
The anticipated total study duration is 42 months.
Exclusion Criteria:
Vinorelbine 35 mg/m2 at day 1 as an i.v. infusion over 10 minutes or gemcitabine 1250 mg/m2 as a 30 minutes infusion at day 1. G-CSF will be started at day 4 at 10mcg/kg b.w. split in two daily doses, until the end of the stem cell collection procedure, with the first collection attempt on day 8.
Drug: Vinorelbine · Drug: Gemcitabine · Drug: G-CSF
G-CSF at 10mcg/kg b.w. split in two daily doses starting from day 1 until the end of the stem cell collection procedure, with the first collection attempt on day 5.
Drug: G-CSF
Stimulation with vinorelbine together with G-CSF for mobilization of autologous stem cells
Stimulation with gemcitabine together with G-CSF for mobilization of autologous stem cells
Cytokine stimulation with G-CSF for mobilization of autologous stem cells
Number of patients achieving a sufficient number of stem cells
Number of patients achieving a sufficient number (at least 5.0 Mio/kg) of stem cells at the planned day in a single day procedure without the use of the rescue compound plerixafor
Time frame: 8 days
Adverse events
Number of patients experiencing toxicities/adverse events assessed according to the CTCAE 5.0 during the study period
Time frame: 30 days after ASCT
Quality of life
Assessment of quality of life before and after mobilization. The EORTC Q30 questionnaire will be given to patients at screening and after mobilization
Time frame: 8 days
Pain
Assessment of pain associated with the mobilization procedure. Pain is measured with visual analogue scale before and after mobilization
Time frame: 8 days
Use of plerixafor
Number of patients requiring plerixafor for mobilization
Time frame: 8 days
Hematologic engraftment after ASCT
First day (after ASCT) of neutrophils rising again above 0.5 G/l, and of platelets rising again above 20 G/L in the absence of platelet transfusions in the previous 3 days.
Time frame: 30 days
Cellular composition of the peripheral blood and the grafts
Standard multiparameter flowcytometric assessment will determine CD4, CD8, sCD3, CD56 and CD19 cellular subsets.
Time frame: 30 days
Flowcytometric MRD levels in the peripheral blood and the grafts
Assessed by standard multiparameter flowcytometry.
Time frame: 30 days
Overall survival
Time from ASCT until death of any cause or date of last follow-up.
Time frame: 60 months
Progression free survival
Time from ASCT until first recurrence of myeloma or date of last follow-up whatever occurs first.
Time frame: 60 months
Plan to share: Yes
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern