drugset / Trial / NCT00603447
Phase 1b Multicenter Study of Carfilzomib With Lenalidomide and Dexamethasone in Relapsed Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
To evaluate the safety and maximum tolerated dose (MTD) of carfilzomib in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma
Timeline
- Start
- 2008-05
- Primary completion
- 2013-05
- Completion
- 2016-01
Publications
- Wang M, Martin T, Bensinger W, Alsina M, Siegel DS, Kavalerchik E, Huang M, Orlowski RZ, Niesvizky R. Phase 2 dose-expansion study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma. Blood. 2013 Oct 31;122(18):3122-8. doi: 10.1182/blood-2013-07-511170. Epub 2013 Sep 6.
- Niesvizky R, Martin TG 3rd, Bensinger WI, Alsina M, Siegel DS, Kunkel LA, Wong AF, Lee S, Orlowski RZ, Wang M. Phase Ib dose-escalation study (PX-171-006) of carfilzomib, lenalidomide, and low-dose dexamethasone in relapsed or progressive multiple myeloma. Clin Cancer Res. 2013 Apr 15;19(8):2248-56. doi: 10.1158/1078-0432.CCR-12-3352. Epub 2013 Feb 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 15 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 27 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 15 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 20 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |