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| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00065351 |
Purpose
For each subject the study will consist of two phases: a treatment phase and a follow-up phase. Screening procedures will take place within 28 days of baseline.
Treatment Phase: Subjects who qualify for enrollment into the study will receive single-agent CC-5013 in 28-day cycles. Study visits will occur every 4 weeks and hematologic and myeloma paraprotein laboratory assessments will occur every 2 weeks for the first 6 cycles and every 4 weeks thereafter.
Follow-Up Phase: All subjects who discontinue the treatment phase for any reason will continue to be followed for survival and post-treatment phase anti-myeloma treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: CC-5013 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Open-label Study to Determine the Safety and Efficacy of Single-agent CC-5013 in Subjects With Relapsed and Refractory Multiple Myeloma |
| Enrollment: | 222 |
| Study Start Date: | July 2003 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
CC-5013 - oral - 30mg daily on days 1-21 every 28 days
|
Drug: CC-5013
CC-5013 - oral - 30mg daily on days 1-21 every 28 days
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A) Absolute neutrophil count (ANC) <1,000 cells/mm^3 (1.0 x 10^9/L) B) Platelet count <75,000/mm^3 (75 x 10^9/L) C) Serum creatinine >2.5 mg/dL (221 umol/L) D) Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN) E) Serum total bilirubin >2.0 mg/dL (34 umol/L)
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Mayo Clinic | |
| Scottsdale, Arizona, United States, 85259 | |
| Palo Verde Hematology Oncology | |
| Glendale, Arizona, United States, 85304 | |
| United States, California | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| Wilshire Oncology Medical Group, Inc. | |
| La Verne, California, United States, 91750 | |
| Providence St. Joseph Medical Center/Cancer Center | |
| Burbank, California, United States, 91505 | |
| Institute for Myeloma and Bone | |
| Los Angeles, California, United States, 90067 | |
| Cancer Care Associates | |
| Redondo Beach, California, United States, 90277 | |
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Georgia | |
| Atlanta Cancer Care-Roswell | |
| Roswell, Georgia, United States, 30076 | |
| Northwest Georgia Oncology Centers | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| Midwest Cancer Research Group | |
| Skokie, Illinois, United States, 60077 | |
| Northwestern University Med Ctr | |
| Chicago, Illinois, United States, 60611-2927 | |
| United States, Maryland | |
| Center for Cancer and Blood Disorders | |
| Bethesda, Maryland, United States, 20717 | |
| University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201-1595 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| University of Massachusetts | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55902 | |
| United States, Nevada | |
| Nevada Cancer Center | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New York | |
| St. Vincent's Comprehensive Cancer Center | |
| New York, New York, United States, 10011 | |
| SUNY Health Science Center at Brooklyn | |
| Brooklyn, New York, United States, 11203 | |
| United States, North Carolina | |
| Carolina Hematology-Oncology Associates | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| Cleveland Clinic Myeloma Program Hematology & Medical Oncology /R35 | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Western Pennsylvania Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Washington | |
| Swedish Cancer Institute | |
| Seattle, Washington, United States, 98104 | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Study Director: | Robert Knight, MD | Celgene Corporation |
More Information
| Responsible Party: | Celgene Corporation ( Robert Knight, MD - VP Hematology ) |
| Study ID Numbers: | CC-5013-MM-014 |
| Study First Received: | July 21, 2003 |
| Last Updated: | September 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00065351 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Myeloma CC-5013 Revlimid |
MM CC5013 relapsed and refractory multiple myeloma |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents Blood Protein Disorders Hematologic Diseases Lenalidomide Vascular Diseases Paraproteinemias |
Hemostatic Disorders Pharmacologic Actions Multiple Myeloma Neoplasms Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Lymphoproliferative Disorders Neoplasms, Plasma Cell |