NCT01010243

Third-line Therapy of Multiple Myeloma a Prospective Phase I /II Trial

Third-line Therapy of Multiple Myeloma With Lenalidomide in Combination With Pioglitazone, Dexamethasone and Metronomic Low-dose Chemotherapy With Treosulfan

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: University of Regensburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Lenalidomide, Pioglitazone, dexamethasone, treosulfan	Phase I:lenalidomide dose ( 5 mg or 10 mg or 15 mg) will be determined for phase II on the basis of DLTs in the first 4 weeks for the phase II part. Start Phase I part: lenalidomide 10 mg p.o. daily + pioglitazone 60 mg p.o. daily + treosulfan 250 mg p.o. bid + dexamethasone initially 40 mg p.o. d1-4 and d15-18, then 20mg d1 and d15. dexamethasone 1 mg p.o. continuously within the intervals of pulsed dexamethasone therapy

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-10-01
• Completion: 2016-10-01
• First posted: 2009-11-09
• Last updated: 2012-05-30

Locations

6 sites across 1 country: Germany