drugset / Trial / NCT00452569
Efficacy and Safety Study of 3 Thalidomide Doses for the Treatment of Relapsed Refractory Multiple Myeloma
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective is to compare the time to progression (TTP) of three daily doses of thalidomide (100, 200 and 400 mg) with high-dose dexamethasone in relapsed refractory multiple myeloma (MM) patients and to subsequently select the optimum thalidomide dose in terms of median TPP and toxicity.
Timeline
- Start
- 2006-02-01
- Primary completion
- 2008-12-01
- Completion
- 2009-01-01
Publications
- Background Kropff M, Baylon HG, Hillengass J, Robak T, Hajek R, Liebisch P, Goranov S, Hulin C, Blade J, Caravita T, Avet-Loiseau H, Moehler TM, Pattou C, Lucy L, Kueenburg E, Glasmacher A, Zerbib R, Facon T. Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial. Haematologica. 2012 May;97(5):784-91. doi: 10.3324/haematol.2011.044271. Epub 2011 Dec 1.
- Background Kropff M, et al. OPTIMUM Dose of Thalidomide for Relapsed Multiple Myeloma. Presented at American Society of Hematology 2009, New Orleans, LA. Abstract No. 959
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Thalidomide | Other / unclassified | 100 mg | Oral |
| Subject | Thalidomide | Other / unclassified | 200 mg | Oral |
| Subject | Thalidomide | Other / unclassified | 400 mg | Oral |