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OncoMatch/Clinical Trials/NCT04973605

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

Is NCT04973605 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for relapsed/refractory multiple myeloma.

Phase 1/2RecruitingBeOne MedicinesNCT04973605Data as of Jun 2026Location: International · 12 countries

Treatment: Sonrotoclax · Dexamethasone · Carfilzomib · Daratumumab · PomalidomideThe 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Daratumumab

Targeted therapy

Carfilzomib

Endocrine / hormonal

Pomalidomide

Other

SonrotoclaxDexamethasone

Cancer type

Multiple Myeloma

Biomarker criteria

Required: CCND1 t(11;14) translocation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: proteasome inhibitor

had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody

Must have received: IMiD

had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody

Must have received: anti-CD38 monoclonal antibody

had ≥ 3 prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 monoclonal antibody

Cannot have received: BCL2 inhibitor (sonrotoclax, venetoclax)

Prior therapy with sonrotoclax or other agents inhibiting BCL2 activity (eg, venetoclax)

Lab requirements

Blood counts

Hemoglobin ≥ 8.0 g/dL (transfusions permitted); Platelet count ≥ 75,000/μL independent of growth factor support and transfusions; ANC ≥ 1000/mm^3

Liver function

ALT and AST ≤ 3 x ULN and total bilirubin ≤ 2.0 x ULN (total bilirubin must be < 3 x ULN for patients with Gilbert's syndrome)

Adequate organ function defined as: Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted); Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment, independent of growth factor support and transfusions; Absolute neutrophil count (ANC) ≥ 1000/mm^3 within 7 days before first dose of study treatment; ALT and AST ≤ 3 x ULN and total bilirubin ≤ 2.0 x ULN (total bilirubin must be < 3 x ULN for patients with Gilbert's syndrome)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Alabama At Birmingham Hospital · Birmingham, Alabama
  • City of Hope National Medical Center · Duarte, California
  • City of Hope Irvine Lennar · Irvine, California
  • University of California At San Francisco · San Francisco, California
  • University of Miami · Miami, Florida

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT04973605 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior BCL2 inhibitor disqualifies patients from enrollment.

Does this trial require CCND1?

Yes, CCND1 t(11;14) translocation is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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