A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy with Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects with Relapsed or Refractory Multiple Myeloma

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506110-43-00

Acronym

M15-654

Enrollment

Registered

2024-05-24

Start date

2018-01-25

Completion date

Unknown

Last updated

2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief summary

Overall response rate (ORR), Very good partial response (VGPR) or better rate, Complete response (CR) or better rate, Time to response (TTR), Duration of response (DOR), Time to progression (TTP), Progression-free survival (PFS), Overall survival (OS)

Detailed description

Minimal Residual Disease (MRD), Safety, Pharmacokinetic (PK) and Biomarker Research Variables

Interventions

DRUGDARZALEX 20 mg/mL concentrate for solution for infusion

DRUGDARZALEX 1800 mg solution for injection

DRUGVELCADE 3.5 mg powder for solution for injection

DRUGVenetoclax

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall response rate (ORR), Very good partial response (VGPR) or better rate, Complete response (CR) or better rate, Time to response (TTR), Duration of response (DOR), Time to progression (TTP), Progression-free survival (PFS), Overall survival (OS)	—

Secondary

Measure	Time frame
Minimal Residual Disease (MRD), Safety, Pharmacokinetic (PK) and Biomarker Research Variables	—

Countries

Denmark, France, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026