Long-Term Follow-up Study for Multiple Myeloma Patients Who Received Study Treatment (Plerixafor or Placebo) in the AMD3100-3102 Study (NCT00103662).

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2011

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).

Interventions

  • Drug: Placebo
  • Drug: plerixafor
  • Drug: granulocyte colony-stimulating factor (G-CSF)

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • All patients who received a dose of study treatment (plerixafor or placebo) in protocol AMD3100-3102 (NCT00103662) Exclusion Criteria:

  • No Exclusion Criteria

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Genzyme, a Sanofi Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Genzyme, a Sanofi Company

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