Phase 3
Completed N=351
A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Source: ClinicalTrials.gov NCT00424047 ↗Enrolled (actual)
351
Serious AEs
52.4%
Results posted
Mar 2015
Primary outcomePrimary: Kaplan-Meier Estimate of Time to Tumor Progression (TTP) — 52.1; 20.1 weeks — p=<0.001
Summary
To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for subjects with relapsed or refractory multiple myeloma."
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Estimate of Time to Tumor Progression (TTP) |
52.1; 20.1 | <0.001 sig |
| PRIMARY Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008) |
52.4; 20.1 | <0.001 sig |
| SECONDARY Kaplan-Meier Estimate of Overall Survival (OS) |
NA; NA | 0.105 |
| SECONDARY Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008) |
161.9; 133.3 | 0.302 |
| SECONDARY Summary of Myeloma Response Rates Based on Best Response Assessment |
15.3; 4.0; 43.8; 19.4; 29.0; 56.6 | <0.001 sig |
| SECONDARY Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008) |
17.0; 4.0; 42.6; 19.4; 28.4; 56.6 | <0.001 sig |
| SECONDARY Number of Participants With Adverse Events (AE) |
176; 175; 105; 79; 46; 31 | — |
| SECONDARY Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone) |
NA; NA | — |
| SECONDARY Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale |
10.1; 12.3 | 0.271 |
| SECONDARY Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008) |
10.1; 12.3 | 0.359 |
Eligibility Criteria
Inclusion Criteria
- Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.
- Measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1, or 2
- Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug
Exclusion Criteria
- Prior development of disease progression during high-dose dexamethasone containing therapy
- Pregnant or lactating females
- The development of a desquamating rash while taking thalidomide
- Use of any standard/experimental anti-myeloma therapy within 28 days of randomization or use of any experimental non-drug therapy within 56 days of initiation of drug treatment
- Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm3
- Laboratory abnormalities: Platelet count 2.5 mg/dL
- Laboratory abnormalities: Serum Serum glutamic oxaloacetic transaminase (SGOT)/Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine aminotransferase (ALT) > 3.0 x upper limit of normal
- Laboratory abnormalities: Serum total bilirubin > 2.0 mg/dL
- Prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for ≥ 3 years.
Data sourced from ClinicalTrials.gov (NCT00424047). 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.