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

2014-07-23 21:11:51 | BioPortfolio

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

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma

Intervention

Lenalidomide, Pioglitazone, dexamethasone, treosulfan

Location

University of Regensburg
Regensburg
Germany
93053

Status

Recruiting

Source

University of Regensburg

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:51-0400

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