Clinical trial · Interventional
CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
A Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
NCT00056160CI-TRIAL-00029963completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CC-5013 | Drug | Lenalidomide | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CC-5013/Dex
- description
- CC-5013 (lenalidomide) plus oral high-dose dexamethasone
- interventionNames
- Drug: CC-5013
- Drug: Dexamethasone
- type
- EXPERIMENTAL
- label
- Placebo/Dex
- description
- Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
- interventionNames
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Time to Tumor Progression (TTP)
- timeFrame
- 60 weeks (median Time To Progression of CC-5013/Dex treatment group)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- RESULTWeber 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. doi: 10.1056/NEJMoa070596. PMID 18032763
- DERIVEDSan-Miguel JF, Dimopoulos MA, Stadtmauer EA, Rajkumar SV, Siegel D, Bravo ML, Olesnyckyj M, Knight RD, Zeldis JB, Harousseau JL, Weber DM. Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):38-43. doi: 10.3816/CLML.2010.n.120. PMID 21273172
- DERIVEDZangari M, Tricot G, Polavaram L, Zhan F, Finlayson A, Knight R, Fu T, Weber D, Dimopoulos MA, Niesvizky R, Fink L. Survival effect of venous thromboembolism in patients with multiple myeloma treated with lenalidomide and high-dose dexamethasone. J Clin Oncol. 2010 Jan 1;28(1):132-5. doi: 10.1200/JCO.2009.23.0169. Epub 2009 Nov 9. PMID 19901114
- DERIVEDWang 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. doi: 10.1182/blood-2008-02-141614. Epub 2008 Sep 17. PMID 18799726