drugset / Trial / NCT01010243
Third-line Therapy of Multiple Myeloma a Prospective Phase I /II Trial
Non-randomizedSingle-groupOpen-labelTreatment
Summary
To investigate the effect of an anti-inflammatory therapy consisting of lenalidomide in combination with pioglitazone, dexamethasone and metronomic low-dose chemotherapy with treosulfan on the response rate in patients with relapsed or refractory or progressive multiple myeloma(MM). Phase I: to determine the lenalidomide dse for the phase II part (5 mg or 10 mg or 15 mg) on the basis of dose-limiting toxicities (DLTs') in the first 4 weeks of treatment. Phase II: to determine * response rate (primary objective) * time to progression (TTP) * time to partial response (TPR) * overall survival (OS) * quality of life * tolerability and safety
Timeline
- Start
- 2009-10
- Primary completion
- 2013-10
- Completion
- 2016-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 5 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 15 mg | Oral |
| Background | Dexamethasone | Small molecule | 1 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Pioglitazone | Small molecule | 60 mg | Oral |
| Background | Treosulfan | Small molecule | 250 mg | Oral |