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

University of Regensburg · 2009
ClinicalTrials.gov · Datasets · License: Public Domain · 2009
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anti-inflammatorymultiple-myelomarelapsed
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
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