Chemotherapy and G-CSF for Mobilization

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT03442673
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    Stimulation with vinorelbine together with G-CSF for mobilization of autologous stem cells
  • Gemcitabine — DRUG
    Stimulation with gemcitabine together with G-CSF for mobilization of autologous stem cells
  • G-CSF — DRUG
    Cytokine stimulation with G-CSF for mobilization of autologous stem cells

Study Details

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.

Key Dates

Start date
Sep 17, 2018
Status verified
Mar 2025
Primary completion
Mar 1, 2023
Completion
May 1, 2024

Study Design

Enrollment
137 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: CG (Chemotherapy/G-CSF) - Regime
    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.
  • Experimental: G (G-CSF) - Regime
    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.

Primary Outcome Measure

Number of patients achieving a sufficient number of stem cells [ Time Frame: 8 days ]

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