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

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).

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Key information

Conditions

Multiple Myeloma Autologous Transplantation Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

No Exclusion Criteria

Treatment and study plan

Placebo

Drug

plerixafor

Drug

Other names: Mozobil, AMD3100

Granulocyte Colony-Stimulating Factor (G-CSF)

Drug

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

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Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Aug 26, 2008
Registry last updated: Mar 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed