| March 6, 2003 |
| September 21, 2009 |
| January 2003 |
| November 2005 (final data collection date for primary outcome measure) |
| Time to tumor progression (TTP) [ Time Frame: randomization to progression ] [ Designated as safety issue: No ] |
| Time to tumor progression (TTP) |
| Complete list of historical versions of study NCT00056160 on ClinicalTrials.gov Archive Site |
| Overall survival. Myeloma response rate. Safety. Time to first symptomatic skeletal-related event (SRE) (clinical need for radiation or surgery to bone). Time to first decrease in ECOG performance status score. [ Time Frame: randomization to progression ] [ Designated as safety issue: Yes ] |
| Overall survival. Myeloma response rate. Safety. Time to first symptomatic skeletal-related event (SRE) (clinical need for radiation or surgery to bone). Time to first decrease in ECOG performance status score. |
| |
| CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma |
| A Multicenter, Parallel-Group, Controlled, Randomized, Double-Blind Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma |
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or identically appearing placebo to CC-5013 plus high-dose dexamethasone, in 4-week cycles. For each subject the study will consist of a treatment phase and a follow-up phase. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Multiple Myeloma |
| Drug: CC-5013 |
| Experimental: CC-5013 |
- Wang M, Dimopoulos MA, Chen C, Cibeira MT, Attal M, Spencer A, Rajkumar SV, Yu Z, Olesnyckyj M, Zeldis JB, Knight RD, Weber DM. Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure. Blood. 2008 Dec 1;112(12):4445-51. Epub 2008 Sep 17.
- Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42.
|
| |
| Completed |
| 351 |
| October 2008 |
| November 2005 (final data collection date for primary outcome measure) |
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 SGOT/AST or SGPT/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.
- The development of a desquamating rash while taking thalidomide.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada |
| |
| NCT00056160 |
| Robert Knight MD - VP Oncology, Celgene Corporation |
| CC-5013-MM-009 |
| Celgene Corporation |
|
| Study Director: |
Robert Knight, MD |
Celgene Corporation |
|
|
| Celgene Corporation |
| September 2009 |
