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
18 Years
N/A
Both
Multiple Myeloma
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Time to Tumor Progression (TTP)
Outcome Description:
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.
Outcome Time Frame:
60 weeks (median Time To Progression of CC-5013/Dex treatment group)
Safety Issue:
No
Principal Investigator
Robert Knight, MD
Investigator Role:
Study Director
Investigator Affiliation:
Celgene Corporation
Authority:
United States: Food and Drug Administration
Study ID:
CC-5013-MM-009
NCT ID:
NCT00056160
Start Date:
January 2003
Completion Date:
October 2008
Related Keywords:
- Multiple Myeloma
- Multiple Myeloma
- Refractory and Relapsed
- Revlimid
- CC5013
- Multiple Myeloma
- Neoplasms, Plasma Cell
Name | Location |
|---|---|
| MD Anderson Cancer Center | Houston, Texas 77030-4096 |
| UCLA School of Medicine | Los Angeles, California 900121973 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
| Loyola University Medical Center | Maywood, Illinois 60153 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| City of Hope National Medical Center | Los Angeles, California 91010 |
| Medical College of Georgia | Augusta, Georgia 30912 |
| University of Pittsburgh | Pittsburgh, Pennsylvania 15261 |
| St. Vincent's Comprehensive Cancer Center | New York, New York 10011 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| SUNY Upstate Medical University | Syracuse, New York 13210 |
| University of Florida | Gainesville, Florida 32610-0277 |
| Oncology Hematology Consultants | Sarasota, Florida 34239 |
| Emory University | Atlanta, Georgia 30322 |
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| Ohio State University | Columbus, Ohio 43210 |
| H Lee Moffitt Cancer Center | Tampa, Florida 33612 |
| Sarah Cannon Cancer Center | Nashville, Tennessee 37203 |
| University of Miami | Miami, Florida 33136 |
| New York Presbyterian Hospital | New York, New York 10021 |
| Yale University School Of Medicine | New Haven, Connecticut 06520 |
| Clinical Research Consultants, Inc. | Hoover, Alabama 35216 |
| UCSF California | San Francisco, California 94143 |
| Stanford University Medical Center, Division of Hematology | Stanford, California 94305-5112 |
| Mayo Clinic- Jacksonville | Jacksonville, Florida 32224 |
| Northwestern University Med Ctr | Chicago, Illinois 60611-2927 |
| Rush Cancer Institute Section of Hematology | Chicago, Illinois 60612-3824 |
| Indiana Cancer Research Institute | Indianapolis, Indiana 46202-5254 |
| University of Iowa Hospital Clinic | Iowa City, Iowa 52242 |
| Ocshner Clinical Foundation | New Orleans, Louisiana 70121 |
| Johns Hopkins Medicine Department of Oncology | Baltimore, Maryland 21231 |
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| Washington University School of Medicine- Sherman Cancer Center | St. Louis, Missouri 63110 |
| MBCCOP Our Lady of Mercy Cancer Center New York Medical College | Bronx, New York 10466 |
| Wake Forest University School of Medicine | Winston-Salem, North Carolina 27157-1023 |
| Cleveland Clinic Myeloma Program | Cleveland, Ohio 44195 |
| Kaiser Permanente Northwest Region Center for Health Research | Portland, Oregon 97227 |
| Charleston Hematology/Oncology P.A. | Charleston, South Carolina 29403 |
| Medical University of SC | Charleston, South Carolina 29425 |
| South Carolina Oncology Group | West Columbia, South Carolina 29169 |
| Froedtert Hospital/BMT Medical College of Wisconsin | Milwaukee, Wisconsin 53226-3522 |
