Spots Global Cancer Trial Database for Third-line Therapy of Multiple Myeloma a Prospective Phase I /II Trial
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Trial Identification
Brief Title: Third-line Therapy of Multiple Myeloma a Prospective Phase I /II Trial
Official Title: Third-line Therapy of Multiple Myeloma With Lenalidomide in Combination With Pioglitazone, Dexamethasone and Metronomic Low-dose Chemotherapy With Treosulfan
Study ID: NCT01010243
Conditions
Study Description
Brief 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
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Schön Klinik Starnberger See, Berg, , Germany
Gemeinschaftspraxis Dres. med. J. Wilke u. H. Wagner, Fürth, , Germany
Universitätsklinikum Schleswig-Holstein, II Medizin, Sekt. f. Stammzell- u. Immuntherapie, Kiel, , Germany
Klinikum d. Universität München, Med. Klinik u. Poliklinik IV, Abt. H/O, München, , Germany
Gemeinschaftspraxis Hämato/Onkologie, München, , Germany
University of Regensburg, Regensburg, , Germany
Contact Details
Name: Albrecht Reichle, Professor
Affiliation: University of Regensburg
Role: PRINCIPAL_INVESTIGATOR
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