Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation|
- Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg [ Time Frame: Day 1 up to day 4 ] [ Designated as safety issue: No ]Number of participants achieving a target of ≥ 4*10^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Target was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.
- Participant Counts of Summarized Adverse Events (AE) During Treatment [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Participant counts of summarized adverse events (AEs) which occurred from the first dose of plerixafor up to the day prior to chemotherapy/ablative treatment. Events were graded according to World Health Organization criteria: Mild (awareness of sign or symptom, but easily tolerated), Moderate (discomfort enough to cause interference with usual activity), Severe (incapacitating with inability to work or do usual activity).
- Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]Polymorphonuclear cell (PMN) engraftment was defined as a PMN count ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1*10^9/L for 1 day. Days to engraftment corresponded to the first day that the criteria were met after transplantation.
- Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment [ Time Frame: Approximately 2 months ] [ Designated as safety issue: No ]Platelet (PLT) engraftment was defined as a PLT count of ≥ 20*10^9/L for 7 days without transfusion. Days to engraftment corresponded to the first day that the criteria were met after transplantation.
- Number of Participants With a Durable Graft at 12 Months Post Transplantation [ Time Frame: Approximately month 13 ] [ Designated as safety issue: No ]Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation.
|Study Start Date:||November 2004|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
Experimental: Participants with Multiple Myeloma (MM)
Participants with MM who were eligible for autologous peripheral blood stem cell transplantation.
Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later. Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4*10^6 CD34+ cells/kg body weight had been collected.
This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if 240 µg/kg plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2*10^6 CD34+ cells/kg and the target is ≧4*10^6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of engraftment will be assessed for a minimum of one year.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396383
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|