CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
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
1 other identifier
interventional
353
2 countries
49
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-myeloma
Started Jan 2003
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 6, 2003
CompletedFirst Posted
Study publicly available on registry
March 7, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
March 3, 2010
CompletedOctober 19, 2017
September 1, 2017
2.8 years
March 6, 2003
December 24, 2009
September 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Tumor Progression (TTP)
Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
60 weeks (median Time To Progression of CC-5013/Dex treatment group)
Secondary Outcomes (3)
Overall Survival
170 weeks (median overall survival of CC-5013/Dex treatment group)
Myeloma Response
Up to Unblinding (07 Jun 2005)
Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)
30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)
Study Arms (2)
CC-5013/Dex
EXPERIMENTALCC-5013 (lenalidomide) plus oral high-dose dexamethasone
Placebo/Dex
EXPERIMENTALPlacebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (49)
Clinical Research Consultants, Inc.
Hoover, Alabama, 35216, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
UCLA School of Medicine
Los Angeles, California, 90095, United States
UCSF California
San Francisco, California, 94143, United States
Stanford University Medical Center, Division of Hematology
Stanford, California, 94305-5112, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
University of Florida
Gainesville, Florida, 32610, United States
Mayo Clinic- Jacksonville
Jacksonville, Florida, 32224, United States
University of Miami
Miami, Florida, 33136, United States
Oncology Hematology Consultants
Sarasota, Florida, 34239, United States
H Lee Moffitt Cancer Center
Tampa, Florida, 33612-9497, United States
Emory University
Atlanta, Georgia, 30322, United States
Medical College of Georgia
Augusta, Georgia, 30912-3125, United States
Northwestern University Med Ctr
Chicago, Illinois, 60611-2927, United States
Rush Cancer Institute Section of Hematology
Chicago, Illinois, 60612-3824, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Indiana Cancer Research Institute
Indianapolis, Indiana, 46202-5254, United States
University of Iowa Hospital Clinic
Iowa City, Iowa, 52242, United States
Ocshner Clinical Foundation
New Orleans, Louisiana, 70121, United States
Johns Hopkins Medicine Department of Oncology
Baltimore, Maryland, 21231, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University Of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Washington University School of Medicine- Sherman Cancer Center
St Louis, Missouri, 63110, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
MBCCOP Our Lady of Mercy Cancer Center New York Medical College
The Bronx, New York, 10466, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1023, United States
Cleveland Clinic Myeloma Program
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Kaiser Permanente Northwest Region Center for Health Research
Portland, Oregon, 97227, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Charleston Hematology/Oncology P.A.
Charleston, South Carolina, 29403, United States
Medical University of SC
Charleston, South Carolina, 29425, United States
South Carolina Oncology Group
West Columbia, South Carolina, 29169, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203-1632, United States
MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Froedtert Hospital/BMT Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3522, United States
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2, Canada
Dalhousie University
Halifax, Nova Scotia, B3H2Y9, Canada
Princess Margaret Hospital
Toronto, Ontario, M5J2M9, Canada
Hospital Charles LeMoyne
Greenfield Park, Quebec, J4V2H1, Canada
McGill University
Montreal, Quebec, PQH2W1S6, Canada
Related Publications (4)
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.
PMID: 18032763RESULTSan-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.
PMID: 21273172DERIVEDZangari 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.
PMID: 19901114DERIVEDWang 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.
PMID: 18799726DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Analyses for efficacy had data cutoff dates of 07 Jun 2005 and a data cutoff date of 23 Jul 2008 for overall survival. Only safety data were collected for 6 subjects ongoing beyond the 23 Jul 2008 data cutoff date.
Results Point of Contact
- Title
- Robert Knight, M.D.
- Organization
- Celgene Corporation
Study Officials
- STUDY DIRECTOR
Robert Knight, MD
Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2003
First Posted
March 7, 2003
Study Start
January 1, 2003
Primary Completion
November 1, 2005
Study Completion
October 1, 2008
Last Updated
October 19, 2017
Results First Posted
March 3, 2010
Record last verified: 2017-09