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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00741780
First Posted: August 26, 2008
Last Update Posted: March 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
  Purpose
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).

Condition Intervention
Multiple Myeloma Autologous Transplantation Drug: Placebo Drug: plerixafor Drug: granulocyte colony-stimulating factor (G-CSF)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome 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 ]

Enrollment: 164
Study Start Date: June 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned 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.
Drug: plerixafor
Other Names:
  • Mozobil
  • AMD3100
Drug: 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.
Drug: Placebo Drug: granulocyte colony-stimulating factor (G-CSF)

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from the AMD3100-3102 study (NCT00103662) who received a at least one dose of study treatment (plerixafor or placebo).
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741780


Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00741780     History of Changes
Other Study ID Numbers: AMD31003102LTF
First Submitted: August 22, 2008
First Posted: August 26, 2008
Last Update Posted: March 24, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lenograstim
JM 3100
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents