This phase III randomized trial compares three different peripheral stem cell mobilization regimens for patients with multiple myeloma who have received primary induction therapy or other therapies. Up to 180 patients will be enrolled. Patients eligible for treatment will be randomized to one of the three following mobilization regimens: Arm A = VELCADE, CYCLOPHOSPHAMIDE, \& G-CSF Arm B = VELCADE \& G-CSF Arm C = CYCLOPHOSPHAMIDE \& G-CSF Arm D = PLERIXAFOR \& G-CSF Arm E = PLERIXAFOR, VELCADE, \& G-CSF
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 Primary Endpoints a) Percentage of patients able to collect \>6 x 106 CD34+ cells/kg in \< 2 collections. Secondary Endpoints 1. Engrafting: Neutrophil recovery (ANC \>0.5 of \<12 days), Plt recovery (\>20K untransfused \<20 days)) after mel 200 based transplant. 2. Toxicities
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
1.3 mg/m2 IVP on days 1, 4, 8 and 11
2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
Emory University
Atlanta, Georgia, United States
New York University Cancer Institute
New York, New York, United States
Columbia Presbyterian Medical Center):
New York, New York, United States
Memorial Sloan-Kettering Cancer Center):
New York, New York, United States
Number of Patients Able to Collect >=6 x 106 CD34+ Cells/kg in <= 2 Collections.
The primary endpoint in all five 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). Note that no patients were enrolled Arm D and Arm E.
Time frame: 36 months
Number of Patients Who Achieved Neutrophil Recovery After Melphalan 200 Based Transplant
Number of patients who achieved neutrophil recovery after Melphalan 200 based transplant in 20 days or fewer. Neutrophil recovery is defined as an absolute neutrophil count of greater than 0.5 k/uL for three consecutive days.
Time frame: 20 days post-transplant
Number of Patients Who Achieved Platelet Recovery After Melphalan 200 Based Transplant
Number of patients who achieved platelet recovery after Melphalan 200 based transplant in 20 days or fewer. Platelet recovery is defined as a platelet count of greater than 20,000, untransfused, for three consecutive days.
Time frame: 20 days post-transplant
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plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
Weill Cornell Medical College
New York, New York, United States