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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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