Vinorelbine and Gemcitabine in Myeloma

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT02791373
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    Mobilisation Chemotherapy
  • Gemcitabine — DRUG
    Mobilisation Chemotherapy

Study Details

The purpose of this study is to determine whether the efficacy of gemcitabine is comparable with the efficacy of the standard chemotherapy with vinorelbine for mobilization of autologous stem cells in myeloma patients

Key Dates

Start date
Mar 31, 2014
Status verified
Mar 2018
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

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

Arms

  • Active Comparator: Mobilisation Chemotherapy: Vinorelbine
    Vinorelbine is given at a standard dose of 35mg/m2 i.v. at day 1 as an infusion over 10 minutes, on an ambulatory basis.
  • Experimental: Mobilisation Chemotherapy: Gemcitabine
    Gemcitabine is given at the standard dose of 1250 mg/m2 i.v. in 500ml NaCl 0.9% (sodium chloride) as an infusion over 30 minutes, on an ambulatory basis.

Primary Outcome Measure

CD34+ (cluster of differentiation 34) peripheral blood stem cells [ Time Frame: Day 8 ]

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