- Active, not recruiting
NCT00644228 : Phase 3 - Lenalidomide and Dexamethasone + / - Bortezomib in NDMM - SWOG S0777
Updated: Jun 22, 2022
Phase III trial SWOG S0777
SWOG0777
0777
Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma
Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma
This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.
Sponsor
National Cancer Institute (NCI)
Multiple locations
International Study
ClinicalTrials.gov Identifier: NCT00644228
Official Title: A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant
First Posted : March 26, 2008
Click here for details on ClinicalTrials.gov
Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial
Longer term follow-up of the randomized phase III trial SWOG S0777: bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone in patients (Pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT)
Drug: Bortezomib
Drug: Dexamethasone
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
- National Cancer Institute NCI
- SWOG: Southwest Oncology Group
- California: Cedars-Sinai Cancer Center Los Angeles
- Arizona: Mayo Clinic Arizona
- Florida: Mayo Clinic Jacksonville Florida
- Arkansas: University of Arkansas Little Rock
- New York: Tisch Cancer Institute Mount Sinai Hospital New York
- New York: NYU Langone Medical Center New York
- New York: University of Rochester New York
- Minnesota: Mayo Clinic Rochester Minnesota
- Massachusetts: Dana-Farber Cancer Institute/Harvard Cancer Center Boston
- New Jersey: Rutgers Cancer Institute of New Jersey New Brunswick
- Ohio: Cleveland Clinic Ohio
- Texas: The University of Texas MD Anderson Cancer Center Houston
Locations
United States, Alaska
United States, Arizona
United States, Arkansas
United States, California
United States, Colorado
United States, Connecticut
United States, Delaware
United States, Florida
United States, Georgia
United States, Hawaii
United States, Illinois
United States, Indiana
United States, Iowa
United States, Kansas
United States, Louisiana
United States, Maine
United States, Maryland
United States, Massachusetts
United States, Michigan
United States, Minnesota
United States, Mississippi
United States, Missouri
United States, Montana
United States, Nevada
United States, New Jersey
United States, New Mexico
United States, New York
United States, North Carolina
United States, North Dakota
United States, Ohio
United States, Oregon
United States, Pennsylvania
United States, Rhode Island
United States, South Carolina
United States, South Dakota
United States, Tennessee
United States, Texas
United States, Virginia
United States, Washington
United States, West Virginia
United States, Wisconsin
United States, Wyoming
Puerto Rico
Saudi Arabia
Principal Investigator: Brian M Durie Southwest Oncology Group