A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects with Multiple Myeloma

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515770-27-00

Enrollment

Registered

2026-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Multiple Myeloma

Brief summary

Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM), Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM, Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM), Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM), Number of Participants with Adverse Events (AE)s

Detailed description

Substudy 1, 2, 3, 4: Complete Response Rate, Substudy 1, 2, 3, 4: Progression Free Survival (PFS), Substudy 1, 2, 3, 4: Duration of Response (DOR), Substudy 1, 2, 3, 4: Overall Response Rate (ORR), Substudy 1, 2, 3, 4: Time-to-Progression (TTP), Substudy 1, 2, 3, 4: Minimal Residual Disease (MRD) negativity

Interventions

DRUGLENALIDOMIDE

DRUGDARATUMUMAB

DRUGEtentamig

DRUGDEXAMETHASONE

DRUGCARFILZOMIB

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM), Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM, Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM), Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM), Number of Participants with Adverse Events (AE)s	—

Measure

Time frame

—

Secondary

Measure	Time frame
Substudy 1, 2, 3, 4: Complete Response Rate, Substudy 1, 2, 3, 4: Progression Free Survival (PFS), Substudy 1, 2, 3, 4: Duration of Response (DOR), Substudy 1, 2, 3, 4: Overall Response Rate (ORR), Substudy 1, 2, 3, 4: Time-to-Progression (TTP), Substudy 1, 2, 3, 4: Minimal Residual Disease (MRD) negativity	—

Outcome results

None listed

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