BGB-11417-105: Phase 1b/2 study of BGB-11417 in Multiple Myeloma
Research type
Research Study
Full title
A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study to Determine the Safety and Efficacy of BGB-11417 as Monotherapy, in Combination With Dexamethasone and Carfilzomib/Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and t(11;14)
IRAS ID
1005586
Contact name
Kajal Patel
Contact email
Sponsor organisation
BeiGene UK, Ltd.
Eudract number
2021-003614-39
Clinicaltrials.gov Identifier
Research summary
This study will enroll people who have been diagnosed with Multiple Myeloma that is either unresponsive to prior treatment or has relapsed. The study will look at the safety and efficacy of an investigational medication currently known as BGB-11417 given on its own, and when given together with a drug called dexamethasone, or when given together with dexamethasone and carfilzomib.
BGB-11417 blocks a protein called B-cell lymphoma-2 (Bcl-2). Bcl-2 helps certain blood cancer cells live and replicate. By blocking Bcl-2, BGB-11417 can slow or stop blood cancer cells replicating and allow natural cell death to occur, thereby causing blood cancer cell death. This may improve the symptoms associated with Multiple Myeloma, prolong periods without disease, and extend survival. However, not all participants will improve to the same degree, and some participants might not improve at all.
Dexamethasone has both an anti-inflammatory effect and an anti-myeloma action.
Carfilzomib belongs to a group of drugs known as proteasome inhibitors and can help to prevent myeloma cells from growing and multiplying.
About 167 participants in total will take part in this study, which will take place in hospitals in multiple countries worldwide. The first participant was enrolled in September 2021 and the study is expected to last approximately 4 years.
Patients who decide to participate will be asked to undergo screening tests and procedures to determine if they qualify to take part in this study. For patients who are eligible, visits and tests will be scheduled during treatment cycles. For participants receiving BGB-11417 on its own or in combination with dexamethasone, cycles will be three weeks, and there will be a visit each week. For participants receiving BGB-11417, dexamethasone and carfilzomib, cycles will be four weeks long, and there will be a visit scheduled every week.
The study is being funded by BeiGene, Ltd.REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0432
Date of REC Opinion
17 Apr 2023
REC opinion
Further Information Favourable Opinion