NCT00114101: Phase 3 - CALGB 100104 - Lenalidomide in Patients With MM Undergoing Auto Transplant

CALGB 100104

Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

NCT00114101: Phase 3 - CALGB 100104 - Lenalidomide in Patients With MM Undergoing Auto Transplant

This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.

CALGB

Sponsor

National Cancer Institute (NCI)

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ClinicalTrials.gov Identifier: NCT00114101

Official Title: A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 (NSC # 703813) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma

First Posted: June 14, 2005

Click here for details on ClinicalTrials.gov

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Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

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PMID: 22571201

NEJM; May 2012

Lenalidomide after stem-cell transplantation for multiple myeloma

PMID: 28826616

Lancet Haematol; Sep 2017

Updated analysis of CALGB (Alliance) 100104 assessing lenalidomide versus placebo maintenance after single autologous stem-cell transplantation for multiple myeloma: a randomised, double-blind, phase 3 trial

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* Lenalidomide (Revlimid)

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- Arizona: Mayo Clinic Arizona

- California: City of Hope Duarte

- California: University of California San Diego

- Florida: Mayo Clinic Jacksonville Florida

- Illinois: University of Chicago Comprehensive Cancer Center

- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston

- Minnesota: Mayo Clinic Rochester Minnesota

- Missouri: Washington University School of Medicine Saint Louis

- New Jersey: Rutgers Cancer Institute of New Jersey New Brunswick

- New York: Roswell Park Cancer Institute Buffalo

- New York: Memorial Sloan-Kettering Cancer Center New York

- New York: New York Presbyterian / Weill Cornell Medical College New York

- New York: University of Rochester New York

- Pennsylvania: University of Pennsylvania Philadelphia

- Pennsylvania: Fox Chase Cancer Center Philadelphia

- Texas: The University of Texas MD Anderson Cancer Center Houston

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Locations

United States, Arizona

United States, California

United States, Colorado

United States, Delaware

United States, District of Columbia

United States, Florida

United States, Georgia

United States, Idaho

United States, Illinois

United States, Indiana

United States, Kansas

United States, Maryland

United States, Massachusetts

United States, Minnesota

United States, Mississippi

United States, Missouri

United States, Nebraska

United States, New Jersey

United States, New Mexico

United States, New York

United States, North Carolina

United States, Ohio

United States, Oregon

United States, Pennsylvania

United States, South Carolina

United States, Tennessee

United States, Texas

United States, Utah

United States, Vermont

United States, Virginia

United States, Washington

United States, West Virginia

United States, Wisconsin

Principal Investigator: Philip L McCarthy

Alliance for Clinical Trials in Oncology