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NCT00056160 : Phase 3 - CC-5013 (lenalidomide) Dex Vs Dex Alone Previously Treated Multiple Myeloma

Updated: Sep 27, 2022

Multiple Myeloma (009)


NCT00056160 : Phase 3 - CC-5013 Plus Dex Versus Dex Alone in Previously Treated Subjects With Multiple Myeloma

Relapsed Refractory Multiple Myeloma

Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.

This was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of CC-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. Eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: Subjects in the CC-5013/Dex treatment group took 25 mg of CC-5013 orally once daily on Days 1 to 21 and a matching placebo capsule once daily on Days 22 to 28 of each 28-day cycle; Subjects in the Placebo/Dex treatment group took 1 placebo capsule on Days 1 to 28 of each 28-day cycle. Subjects in both treatment groups took 40 mg of dexamethasone orally once daily on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. Beginning with Cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on Days 1 to 4 for the remaining cycles.

Sponsor Identifier: NCT00056160

Official Title: A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

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Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22

Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone.

Clin Lymphoma Myeloma Leuk. 2011 Feb;11

Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone.

J Clin Oncol. 2010 Jan

Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure.

Blood. 2008 Dec


Related Study:

Two identically designed, multicenter, double-blind, phase III clinical trials (MM-009 and MM-010) were conducted in Europe and the United States to assess the effect of lenalidomide in combination with dexamethasone versus dexamethasone plus placebo


- Lenalidomide (Revlimid)

- Dexamethasone (Decadron)


- California: University of California San Francisco

- California: City of Hope Duarte

- California: UCLA School of Medicine Los Angeles

- Connecticut: Yale University New Haven

- Florida: Mayo Clinic Jacksonville Florida

- Florida: Moffitt Cancer Center Tampa

- Florida: Sylvester Comprehensive Cancer Center - University of Miami

- Georgia: Emory University Atlanta

- Iowa: University of Iowa Iowa city

- Maryland: Johns Hopkins Baltimore

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

- Missouri: Washington University School of Medicine Saint Louis

- Minnesota: Mayo Clinic Rochester Minnesota

- New Jersey: Hackensack University Medical Center

- New York: Roswell Park Cancer Institute Buffalo

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

- Pennsylvania: University of Pennsylvania Philadelphia

- North Carolina: Wake Forest Baptist Health Winston-Salem

- Pennsylvania: University of Pittsburgh Medical Center

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

- Tennessee: Sarah Cannon Research Institute Nashville



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