Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Granulocyte colony-stimulating factor plus plerixafor
Drug: Granulocyte colony-stimulating factor plus placebo

Registration Number: NCT00103662

Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 302

Inclusion Criteria

Diagnosis of multiple myeloma in first or second complete or partial remission
>= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)
Recovered from all acute toxic effects of prior chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
White Blood Cell count (WBC) > 2.5*10^9/L
Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L
Platelet (PLT) > 100*10^9/L
Serum creatinine <=2.2 mg/dL
Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
Negative for HIV

Exclusion Criteria):

Failed previous stem cell collection
Previous stem cell transplantation
Brain metastases or myelomatous meningitis
Radiation to ≥ 50% of the pelvis
Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
Received bone-seeking radionuclides (e.g. holmium)
A residual acute medical condition resulting from prior chemotherapy

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-CSF plus plerixafor	Granulocyte colony-stimulating factor plus plerixafor	-
G-CSF plus placebo	Granulocyte colony-stimulating factor plus placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.	up to Day 6	Proportion of participants achieving a target of ≥ 6\*10\^6 CD34+ cells/kg in 2 or fewer days of apheresis. Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.

Secondary Outcome Measures

Name	Time	Method
Graft Durability at 100 Days Post Transplantation	approximately Day 138	The proportion of participants maintaining a durable graft at 100 days post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment	Up to Month 13	The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5\10\^9/L for 3 consecutive days or ≥ 1.0\10\^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
Number of Participants With Adverse Events	up to Day 38	Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.
Median Number of Days to ≥6*10^6 CD34+ Cells/kg	up to Day 8	The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6\*10\^6 CD34+ cells/kg) for transplantation.
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.	up to Day 8	Proportion of participants achieving a target of ≥ 6\*10\^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.	up to Day 8	Proportion of participants achieving a target of ≥ 2\*10\^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
Graft Durability at 6 Months Post Transplantation	approximately Month 7	The proportion of participants maintaining a durable graft at 6 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.
Median Number of Days to Platelet (PLT) Engraftment	Up to Month 13	The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20\*10\^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
Graft Durability at 12 Months Post Transplantation	approximately Month 13	The proportion of participants maintaining a durable graft at 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count \>50000/µL without transfusion for at least 2 weeks, (2) hemoglobin \>=10g/dL for at least 1 month, (3) and absolute neutrophil count \>1000/µL for at least 1 week.

Trial Locations

Locations (39): City of Hope Samaritan Bone Marrow Transplant Program
🇺🇸
Phoenix, Arizona, United States
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
City of Hope National Medical Center
🇺🇸
Duarte, California, United States
Cedars-Sinai
🇺🇸
Los Angeles, California, United States
University of California
🇺🇸
Los Angeles, California, United States
Rocky Mountain Cancer Center
🇺🇸
Denver, Colorado, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸
Tampa, Florida, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
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City of Hope Samaritan Bone Marrow Transplant Program
🇺🇸Phoenix, Arizona, United States