• Active, not recruiting

NCT00644228 : Phase 3 - Lenalidomide and Dexamethasone + / - Bortezomib in NDMM - SWOG S0777

Updated: Jun 22

Phase III trial SWOG S0777

SWOG0777

0777


Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

swog s0777

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


S0777 | SWOG


SWOG

 

Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

 

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

Lancet, Feb 2017


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)

Blood Cancer J; 2020 May

 

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




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