Last updated on May 2012

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


Brief description of study

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

Clinical Study Identifier: NCT01010243

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