Mobilization of CD34+ cells with standard or reduced dose filgrastim after vinorelbine in multiple myeloma patients. A randomized prospecitve single center phase II study.
Phase 2
- Conditions
- C90.0Multiple myeloma
- Registration Number
- DRKS00003251
- Lead Sponsor
- niversität Zürich
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
All patients with multiple myeloma planned to undergo ASCT. Patients planned to receive vinorelbine for CD34+ cell mobilisation. No more than 1 induction chemotherapy (steroids only are allowed). Written informed consent.
Exclusion Criteria
Known hypersensitivity or allergy to filgrastim (Neupogen®). Active Hepatitis B/C or HIV-infection. Treatment with other investigational products. Participation in another study with investigational drug. Inability to follow the procedures of the study. Known or suspected non-compliance. Drug or alcohol abuse. Pregnancy or breast feeding. Contraindications on ethical grounds.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of reduced dose filgrastim for mobilization of CD34+ stem cells in myeloma patients after vinorelbine administration.<br>Number of aphereses neccessary. Median number of CD34+ stem cells collected.<br><br>
- Secondary Outcome Measures
Name Time Method Cost comparison between the two treatment arms. Evaluation of the cost of filgrastim and the cost of required analgesics. Bone pain assessment. Immune monitoring. Validation of CD 133 as alternative stem cell marker.<br><br>