drugset / Trial / NCT00507442
Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients
Phase 1/2
Completed
158 enrolled
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and Dexamethasone will increase the complete response (CR)/ very good partial response (VGPR) rate.
Timeline
- Start
- 2007-08
- Primary completion
- 2010-10
- Completion
- 2010-11
Publications
- Kumar S, Flinn I, Richardson PG, Hari P, Callander N, Noga SJ, Stewart AK, Turturro F, Rifkin R, Wolf J, Estevam J, Mulligan G, Shi H, Webb IJ, Rajkumar SV. Randomized, multicenter, phase 2 study (EVOLUTION) of combinations of bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in previously untreated multiple myeloma. Blood. 2012 May 10;119(19):4375-82. doi: 10.1182/blood-2011-11-395749. Epub 2012 Mar 15.
- Kumar SK, Flinn I, Noga SJ, Hari P, Rifkin R, Callander N, Bhandari M, Wolf JL, Gasparetto C, Krishnan A, Grosman D, Glass J, Sahovic EA, Shi H, Webb IJ, Richardson PG, Rajkumar SV. Bortezomib, dexamethasone, cyclophosphamide and lenalidomide combination for newly diagnosed multiple myeloma: phase 1 results from the multicenter EVOLUTION study. Leukemia. 2010 Jul;24(7):1350-6. doi: 10.1038/leu.2010.116. Epub 2010 May 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 100 mg/m2 | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 200 mg/m2 | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 400 mg/m2 | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Oral |
| Subject | Lenalidomide | Other / unclassified | 15 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Background | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |