A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma

2024-517140-65-00 · tracked via the Priya Life Science EU tracker

Sponsor

AbbVie Deutschland GmbH & Co. KG

Sponsor type

Pharmaceutical company

Therapeutic area

Neoplasms

Decision date

06/10/2025

Enrollment target

Sites

Belgium, Portugal, Sweden, Italy, France, Poland, Germany

Condition studied

Multiple Myeloma (MM).

Investigational medicinal product(s)

SurzetoclaxDEXAMETHASONEDEXAMETHASONEDARATUMUMABPOMALIDOMIDEPOMALIDOMIDEPOMALIDOMIDESurzetoclaxDEXAMETHASONE

Eligibility

Age group

18-64 years, 65+ years

Sex

Female, Male

Primary endpoint

Dose Limiting Toxicities (DLT)s of surzetoclax, Safety and tolerability (AEs and SAEs, clinical laboratory parameters, vital sign measurements, and ECG results).

Endpoint detail

Overall Response Rate (ORR), Progression-Free Survival (PFS), Duration of Response (DOR), Time-to-Progression (TTP), Time to Next Treatment, Rate of minimal residual disease (MRD) Negativity Determined Centrally, , using Adaptive's clonoSEQ Next Generation Sequencing (NGS) assay, Overall survival (OS)

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-517140-65-00 on CTIS ↗ ← All trials in the EU