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
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).
Observational
Time Perspective: Prospective
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)
5 years
No
Medical Monitor
Study Director
Genzyme
United States: Food and Drug Administration
AMD31003102LTF
NCT00741780
June 2006
July 2011
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