Phase 3
Completed N=353
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Source: ClinicalTrials.gov NCT00056160 ↗Enrolled (actual)
353
Serious AEs
57.1%
Results posted
Mar 2010
Primary outcomePrimary: Time to Tumor Progression (TTP) — 60.1; 20.1 Weeks
Summary
Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Tumor Progression (TTP) |
60.1; 20.1 | — |
| SECONDARY Overall Survival |
170.1; 136.4 | — |
| SECONDARY Myeloma Response |
107; 34 | — |
| SECONDARY Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.) |
29.9; 15.0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00056160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.