Long-term Observational Follow-up Study of a Multicenter, Randomized, Double-blind, Placebo-controlled, Comparative Trial of AMD3100 (240µg/kg) Plus G-CSF (10µg/kg) Versus G-CSF (10µg/kg) Plus Placebo to Mobilize and Collect ≥ 6X 10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation
Overview
- Phase
- Not Applicable
- Intervention
- plerixafor
- Conditions
- Multiple Myeloma
- Sponsor
- Genzyme, a Sanofi Company
- Enrollment
- 164
- Primary Endpoint
- Progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This is a long-term observational study of patients that were treated with at least 1 dose of study treatment (plerixafor or placebo) in the AMD3100-3102 protocol (NCT00103662).
Detailed Description
This is a long-term observational study of patients who received at least one dose of study treatment (plerixafor or placebo) in a multicenter, randomized, double blind, placebo-controlled study to evaluate AMD3100 plus granulocyte colony stimulating factor (GCSF) versus G-CSF plus placebo to mobilize and transplant Multiple Myeloma (MM) patients (protocol AMD31003102LTF \[NCT00103662\]). The objective of this study is to assess progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) for a period of 5 years following the first dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662).
Investigators
Eligibility Criteria
Inclusion Criteria
- •All patients who received a dose of study treatment (plerixafor or placebo) in protocol AMD3100-3102 (NCT00103662)
Exclusion Criteria
- •No Exclusion Criteria
Arms & Interventions
G-CSF plus plerixafor
Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received plerixafor prior to undergoing apheresis.
Intervention: plerixafor
G-CSF plus plerixafor
Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received plerixafor prior to undergoing apheresis.
Intervention: granulocyte colony-stimulating factor (G-CSF)
G-CSF plus placebo
Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received placebo prior to undergoing apheresis.
Intervention: Placebo
G-CSF plus placebo
Participants in AMD3100-3102 (NCT00103662) who underwent mobilization with granulocyte colony-stimulating factor (G-CSF) and received placebo prior to undergoing apheresis.
Intervention: granulocyte colony-stimulating factor (G-CSF)
Outcomes
Primary Outcomes
Progression-free survival and overall survival of patients treated with at least 1 dose of study treatment (placebo or plerixafor) in protocol AMD3100-3102 (NCT00103662)
Time Frame: 5 years