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CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

NCT ID: NCT00056160

Last Updated: 2017-10-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-01

Study Completion Date

2008-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma

Keywords

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Multiple Myeloma Refractory and Relapsed Revlimid CC5013

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CC-5013/Dex

CC-5013 (lenalidomide) plus oral high-dose dexamethasone

Group Type EXPERIMENTAL

CC-5013

Intervention Type DRUG

Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide 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.

Dexamethasone

Intervention Type DRUG

Subjects in the CC-5013/Dex and Placebo/Dex 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.

Placebo/Dex

Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Subjects in the CC-5013/Dex and Placebo/Dex 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.

Interventions

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CC-5013

Subjects in the CC-5013/Dex treatment group took 25 mg of lenalidomide 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.

Intervention Type DRUG

Dexamethasone

Subjects in the CC-5013/Dex and Placebo/Dex 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.

Intervention Type DRUG

Other Intervention Names

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lenalidomide Revlimid Decadron

Eligibility Criteria

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Inclusion Criteria

* Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.
* No more than 3 previous anti-myeloma regimens
* No high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization.
* Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).

Exclusion Criteria

* Prior development of disease progression during high-dose dexamethasone containing therapy.
* Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm cubed
* Laboratory abnormalities: Platelet count less than 75,000/mm cubed
* Laboratory abnormalities: Serum creatinine greater than 2.5 mg/dL
* Laboratory abnormalities: Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase \[AST\]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase \[ALT\])greater than 3.0 x upper limit of normal
* Laboratory abnormalities: Serum total bilirubin greater than 2.0 mg/dL
* Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years.
* Known hypersensitivity to thalidomide or dexamethasone.
* Development of a desquamating rash while taking thalidomide.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Knight, MD

Role: STUDY_DIRECTOR

Celgene Corporation

Locations

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Clinical Research Consultants, Inc.

Hoover, Alabama, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

UCLA School of Medicine

Los Angeles, California, United States

Site Status

UCSF California

San Francisco, California, United States

Site Status

Stanford University Medical Center, Division of Hematology

Stanford, California, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Mayo Clinic- Jacksonville

Jacksonville, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Oncology Hematology Consultants

Sarasota, Florida, United States

Site Status

H Lee Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Medical College of Georgia

Augusta, Georgia, United States

Site Status

Northwestern University Med Ctr

Chicago, Illinois, United States

Site Status

Rush Cancer Institute Section of Hematology

Chicago, Illinois, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Indiana Cancer Research Institute

Indianapolis, Indiana, United States

Site Status

University of Iowa Hospital Clinic

Iowa City, Iowa, United States

Site Status

Ocshner Clinical Foundation

New Orleans, Louisiana, United States

Site Status

Johns Hopkins Medicine Department of Oncology

Baltimore, Maryland, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

University Of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Site Status

Washington University School of Medicine- Sherman Cancer Center

St Louis, Missouri, United States

Site Status

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

St. Vincent's Comprehensive Cancer Center

New York, New York, United States

Site Status

New York Presbyterian Hospital

New York, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

MBCCOP Our Lady of Mercy Cancer Center New York Medical College

The Bronx, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Cleveland Clinic Myeloma Program

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Kaiser Permanente Northwest Region Center for Health Research

Portland, Oregon, United States

Site Status

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Charleston Hematology/Oncology P.A.

Charleston, South Carolina, United States

Site Status

Medical University of SC

Charleston, South Carolina, United States

Site Status

South Carolina Oncology Group

West Columbia, South Carolina, United States

Site Status

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Froedtert Hospital/BMT Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Dalhousie University

Halifax, Nova Scotia, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Hospital Charles LeMoyne

Greenfield Park, Quebec, Canada

Site Status

McGill University

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

References

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Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.

Reference Type RESULT
PMID: 18032763 (View on PubMed)

San-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. 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(1):38-43. doi: 10.3816/CLML.2010.n.120.

Reference Type DERIVED
PMID: 21273172 (View on PubMed)

Zangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. doi: 10.1200/JCO.2009.23.0169. Epub 2009 Nov 9.

Reference Type DERIVED
PMID: 19901114 (View on PubMed)

Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. 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 1;112(12):4445-51. doi: 10.1182/blood-2008-02-141614. Epub 2008 Sep 17.

Reference Type DERIVED
PMID: 18799726 (View on PubMed)

Related Links

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http://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/clinical-study-report-csr-synopses/purposes-of-posting-clinical-study-report-csr-synopses

Link to CSR synopsis

Other Identifiers

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CC-5013-MM-009

Identifier Type: -

Identifier Source: org_study_id