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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: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: 1
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
Show 26 Study Locations| Study Director: | Robert Knight, MD | Celgene Corporation |
More Information
| Responsible Party: | Robert Knight, MD - VP Hematology, Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00065351 History of Changes |
| Other Study ID Numbers: | CC-5013-MM-014 |
| Study First Received: | July 21, 2003 |
| Last Updated: | September 22, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Myeloma CC-5013 Revlimid |
MM CC5013 relapsed and refractory multiple myeloma |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Lenalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |