A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

The purpose of this study is to assess the safety, tolerability, and efficacy of sonrotoclax as monotherapy and in various combinations in patients with relapsed/refractory (R/R) multiple myeloma (MM) and chromosomal translocation t(11;14).

The study investigates sonrotoclax alone and in combination with dexamethasone and other agents, including carfilzomib, daratumumab, and pomalidomide.

Eligibility criteria

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/or urine)

Participant has documented relapsed or progressive MM on or after any regimen or who are refractory to the most recent line of therapy.

In Part 1 and Part 2 Cohorts 1 and 2 participants should have relapsed or progressive disease and have had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody, and no more available approved therapies.

Disqualifiers

Non secretory MM (Serum free light chains < 10 mg/dL)

Solitary plasmacytoma

Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or > 2.0 x 109/L circulating plasma cells by standard differential)

Waldenström macroglobulinemia (WM)

Trial design

Treatments tested in this trial

  • Sonrotoclax
  • Dexamethasone
  • Carfilzomib
  • Daratumumab
  • Pomalidomide

Treatment groups

246 Participants
are divided into 2 treatment groups

Sponsors and collaborators