Know Cancer

or
forgot password

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


N/A
N/A
N/A
Not Enrolling
Both
Multiple Myeloma, Autologous Transplantation

Thank you

Trial Information

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).


Inclusion Criteria:



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

Exclusion Criteria:

- No Exclusion Criteria

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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)

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

AMD31003102LTF

NCT ID:

NCT00741780

Start Date:

June 2006

Completion Date:

July 2011

Related Keywords:

  • Multiple Myeloma
  • Autologous Transplantation
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location