CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
- Registration Number
- NCT00056160
- Lead Sponsor
- Celgene
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CC-5013/Dex CC-5013 CC-5013 (lenalidomide) plus oral high-dose dexamethasone CC-5013/Dex Dexamethasone CC-5013 (lenalidomide) plus oral high-dose dexamethasone Placebo/Dex Dexamethasone Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
- Primary Outcome Measures
Name Time Method Time to Tumor Progression (TTP) 60 weeks (median Time To Progression of CC-5013/Dex treatment group) 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.
- Secondary Outcome Measures
Name Time Method Overall Survival 170 weeks (median overall survival of CC-5013/Dex treatment group) Overall survival was calculated as the time from randomization to death from any cause.
Myeloma Response Up to Unblinding (07 Jun 2005) The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.
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) The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.
Trial Locations
- Locations (49)
Ohio State University
🇺🇸Columbus, Ohio, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Clinical Research Consultants, Inc.
🇺🇸Hoover, Alabama, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Stanford University Medical Center, Division of Hematology
🇺🇸Stanford, California, United States
Mayo Clinic- Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Oncology Hematology Consultants
🇺🇸Sarasota, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Rush Cancer Institute Section of Hematology
🇺🇸Chicago, Illinois, United States
Northwestern University Med Ctr
🇺🇸Chicago, Illinois, United States
University of Iowa Hospital Clinic
🇺🇸Iowa City, Iowa, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
UCSF California
🇺🇸San Francisco, California, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
University of Miami
🇺🇸Miami, Florida, United States
Indiana Cancer Research Institute
🇺🇸Indianapolis, Indiana, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Kaiser Permanente Northwest Region Center for Health Research
🇺🇸Portland, Oregon, United States
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
Froedtert Hospital/BMT Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
H Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
South Carolina Oncology Group
🇺🇸West Columbia, South Carolina, United States
McGill University
🇨🇦Montreal, Quebec, Canada
Charleston Hematology/Oncology P.A.
🇺🇸Charleston, South Carolina, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Cleveland Clinic Myeloma Program
🇺🇸Cleveland, Ohio, United States
Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
St. Vincent's Comprehensive Cancer Center
🇺🇸New York, New York, United States
Washington University School of Medicine- Sherman Cancer Center
🇺🇸Saint Louis, Missouri, United States
MBCCOP Our Lady of Mercy Cancer Center New York Medical College
🇺🇸The Bronx, New York, United States
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Hospital Charles LeMoyne
🇨🇦Greenfield Park, Quebec, Canada
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Johns Hopkins Medicine Department of Oncology
🇺🇸Baltimore, Maryland, United States
University Of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Ocshner Clinical Foundation
🇺🇸New Orleans, Louisiana, United States
Medical University of SC
🇺🇸Charleston, South Carolina, United States