NCT02834364

BRAF/MEK Inhibition in Relapsed/Refractory Multiple Myeloma (BIRMA)

LGX818 in Combination With MEK162 in Refractory or Relapsed Multiple Myeloma Patients With BRAFV600E or BRAFV600K Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Heidelberg Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed or Refractory Multiple Myeloma
• Patients With BRAFV600 E or BRAFV600K Mutation

Interventions

Type	Name	Description
DRUG	Encorafenib	450 mg p.o. once daily. One cycle is defined as 28 days
DRUG	Binimetinib	45 mg p.o. twice daily. One cycle is defined as 28 days

Timeline

• Start date: 2016-06-01
• Primary completion: 2023-03-29
• Completion: 2023-03-29
• First posted: 2016-07-15
• Last updated: 2023-11-24

Locations

7 sites across 1 country: Germany