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Surzetoclax in Relapsed/Refractory Multiple Myeloma
NCT06953960Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2025
- Primary completion
- Dec 2030
- Countries
- 12
- Sponsor
- AbbVie Inc.
- Modality
- Small Molecules
- Drugs
- surzetoclax
- Conditions
- multiple myeloma (MM)
01
Overview
Phase 2, randomised, open-label trial of surzetoclax in multiple myeloma (MM) (8 arms), sponsored by AbbVie Inc. Primary endpoints: Dose-Limiting Toxicities at 45 months and Adverse Events at 4.5 years. Started Jul 2025; status: recruiting.
02
Design
8 arms- Study design
- RandomizedOpen-label
Substudy 1: Dose Escalation Surzetoclax Combination
Surzetoclax + Daratumumab + Dexamethasone
Substudy 1: Dose Optimization & Selection ABBV-453 Combination
Surzetoclax + Daratumumab + Dexamethasone
Substudy 1: Dose Optimization & Selection Control
Daratumumab + Dexamethasone + Pomalidomide
Substudy 2: Dose Escalation ABBV-453 Monotherapy
Surzetoclax monotherapy
Substudy 3: Dose Escalation Surzetoclax + Etentamig
Surzetoclax + Etentamig
Substudy 3: Dose Optimization Etentamig Dose A Combination
Surzetoclax + Etentamig Dose A
2 more in the full profile.
03
Who it enrols
Adults with relapsed/refractory multiple myeloma, BCL-2 inhibitor naive, t(11;14) positive and/or BCL2 high, with measurable disease.
04
Endpoints
Primary
Dose-Limiting Toxicities
Adverse Events
Secondary
Overall Response Rate
Progression-Free Survival
Duration of Response
Time-to-Progression
Time to Next Treatment
Minimal Residual Disease Negativity
Overall Survival
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