Multiple Myeloma Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.
A peripheral stem cell transplant may be able to replace blood-forming cells that were
destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is
used to cause the growth and mobilization of stem cells from bone marrow to peripheral
blood, which can then be collected from the peripheral blood by a process called apheresis.
Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral
blood, possibly allowing for a more rapid collection of a larger number of stem cells from
the peripheral blood. Larger stem cell doses for transplantation correlate to faster
recovery times after high dose chemotherapy followed with stem cell transplantation. This
study is intended to determine whether the combination of plerixafor with filgrastim
(G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect
at least 6 million stem cells in two or less apheresis sessions.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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