|
|
|
|
|
|
Sponsored by: |
Celgene Corporation |
Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00065351 |
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 |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Cancer Multiple Myeloma |
ChemIDplus related topics: | Lenalidomide CC 5013 |
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 |
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)
Show 26 Study Locations |
Celgene Corporation |
Study ID Numbers: | CC-5013-MM-014 |
First Received: | July 21, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00065351 |
Health Authority: | United States: Food and Drug Administration |
|
|
|
|
|
|