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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
BeOne Medicines
Study ID
NCT04973605
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sonrotoclax — DRUG
    Administered orally daily
  • Dexamethasone — DRUG
    Once weekly either orally or intravenously
  • Carfilzomib — DRUG
    Administered intravenously weekly
  • Daratumumab — DRUG
    Administered subcutaneously weekly
  • Pomalidomide — DRUG
    Administered orally daily

Study Details

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.

Key Dates

Start date
Sep 16, 2021
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
246 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Dose Escalation
    Dose-escalation and de-escalation to determine maximum tolerated dose (MTD) of sonrotoclax plus dexamethasone, sonrotoclax plus dexamethasone plus carfilzomib, sonrotoclax plus dexamethasone plus daratumumab, and sonrotoclax plus dexamethasone plus pomalidomide.
  • Experimental: Part 2 Cohort Expansion
    There will be up to 7 expansion cohorts to further evaluate the safety and efficacy of sonrotoclax monotherapy, sonrotoclax plus dexamethasone in combination with dexamethasone plus carfilzomib, and in combination with dexamethasone plus daratumumab

Primary Outcome Measure

Part 1: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
University of Alabama At Birmingham HospitalBirminghamAlabama35294-0004-
City of Hope National Medical CenterDuarteCalifornia91010-3012-
City of Hope Irvine LennarIrvineCalifornia92618-2377-
University of MiamiMiamiFlorida33136-2107-
Emory University Winship Cancer CenterAtlantaGeorgia30322-1013-
University of Chicago Medical CenterChicagoIllinois60637-1443-
Massachusetts General HospitalBostonMassachusetts02114-
Washington University School of MedicineSt LouisMissouri63110-1010-
Hackensack University Medical CenterHackensackNew Jersey07601-1915-
Memorial Sloan Kettering Cancer Center MskccNew YorkNew York10065-6800-
Weill Cornell Medical College Newyork Presbyterian HospitalNew YorkNew York10065-4870-
The James Cancer Hospital and Solove Research Institute At Ohio State UniversityColumbusOhio43210-1240-
Huntsman Cancer InstituteSalt Lake CityUtah84112-5550-
University of WashingtonSeattleWashington98195-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-0001-
Medical College of WisconsinMilwaukeeWisconsin53226-1222-

Find similar trials in Birmingham, AL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Alabama At Birmingham Hospital· Birmingham, ALCity of Hope National Medical Center· Duarte, CACity of Hope Irvine Lennar· Irvine, CAUniversity of Miami· Miami, FLEmory University Winship Cancer Center· Atlanta, GAUniversity of Chicago Medical Center· Chicago, IL

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