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Spots Global Cancer Trial Database for BRAF/MEK Inhibition in Relapsed/Refractory Multiple Myeloma (BIRMA)

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Marc S. Raab, PD Dr. med.

Affiliation: Medizinische Klinik V, University Hospital Heidelberg

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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