NCT00103662
Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
PHASE3
COMPLETED
NCT00103662
INTERVENTIONAL
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.
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
Multiple Myeloma
- TREATMENT
-
- Type: DRUG
- Name: Granulocyte colony-stimulating factor plus plerixafor
- Description: Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
- Arm Group Labels: G-CSF plus plerixafor
-
- Type: DRUG
- Name: Granulocyte colony-stimulating factor plus placebo
- Description: Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection. On the evening of Day 4, participants received placebo, administered by SC injection. On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx. 10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration). Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected. Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
- Arm Group Labels: G-CSF plus placebo
- Genzyme, a Sanofi Company