Third-line Therapy of Multiple Myeloma a Prospective Phase I /II Trial
Status:
Unknown status
Trial end date:
2016-10-01
Target enrollment:
Participant gender:
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