A Prospective Randomized Trial Comparing Three Different Peripheral Stem Cell Mobilization Regimens in Patients With Symptomatic Multiple Myeloma
PRIMARY STUDY OBJECTIVES
• To compare the efficacy of the following peripheral stem cell mobilization regimens for
MM: i. High dose cyclophosphamide, VELCADE, and G-CSF ii. VELCADE and G-CSF iii. High dose
cyclophosphamide and G-CSF
SECONDARY STUDY OBJECTIVES
• To evaluate biomarkers as surrogate markers of mobilization in each arm To evaluate
changes in tumor mass as defined by standard response parameters. To evaluate the safety of
each of the arms.
This phase III randomized trial compares three different peripheral stem cell mobilization
regimens for patients with multiple myeloma who have received primary induction therapy
a) Percentage of patients able to collect >6 x 106 CD34+ cells/kg in < 2 collections.
1. Engrafting: Neutrophil recovery (ANC >0.5 of <12 days), Plt recovery (>20K untransfused
<20 days)) after mel 200 based transplant.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients able to collect >6 x 106 CD34+ cells/kg in < 2 collections.
The primary endpoint in all three treatment arms is the percentage of patients who are able to achieve greater than 6 x 106 CD34+ stems cells/kg harvested (defined as effectiveness).
Ruben Niesvizky, MD
Weill Medical College of Cornell University
United States: Institutional Review Board
|Weill Cornell Medical College||New York, New York 10021|