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Brief Title: BRAF/MEK Inhibition in Relapsed/Refractory Multiple Myeloma (BIRMA)
Official Title: LGX818 in Combination With MEK162 in Refractory or Relapsed Multiple Myeloma Patients With BRAFV600E or BRAFV600K Mutation
Study ID: NCT02834364
Brief Summary: Trial for patients with refractory multiple myeloma after failure of at least two treatment regimens and with BRAFV600E/K Mutation to evaluate the efficacy of the kinase inhibitors Encorafenib (LGX818 in) combination with Binimetinib (MEK162).
Detailed Description: An open-label, single-arm, multi-centre phase II trial for patients with refractory multiple myeloma and with BRAFV600E/K Mutation to evaluate the efficacy of the kinase inhibitors Encorafenib (LGX818 in) combination with Binimetinib (MEK162). The patients must have received at least two prior therapy regimen (at least one immunomodulatory drug and one proteasome inhibitor). The subjects receive LGX 818 450 mg. p.o. once daily and MEK 162 45 mg p.o. twice daily until disease progression or toxicity requiring discontinuation of treatment. 1 cycle is defined as 28 days.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mediz. Klinik und Poliklinik 1, Universitätsklinikum Dresden, Dresden, , Germany
Universitätsklinikum Frankfurt, Medizinische Klinik II, Frankfurt/Main, , Germany
University Hospital Heidelberg, Med. Klinik V, Heidelberg, , Germany
Universitätsklinikum Köln, Klinik I Innere Medizin, Köln, , Germany
Universitätsklinikum Münster, Med. Klinik und Poliklinik A, Münster, , Germany
Universitätsklinikum Tübingen, Medizinische Klinik II, Tübingen, , Germany
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Würzburg, , Germany
Name: Marc S. Raab, PD Dr. med.
Affiliation: Medizinische Klinik V, University Hospital Heidelberg
Role: PRINCIPAL_INVESTIGATOR