Etenta-Isa-VRd in Newly Diagnosed High-Risk Multiple Myeloma

Sponsor
Universitätsklinikum Hamburg-Eppendorf
Study ID
NCT07600151
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Etentamig — DRUG
    Administered per the protocol
  • Isatuximab — DRUG
    Administered per the protocol
  • Bortezomib + Lenalidomide + Dexamethasone — DRUG
    Administered per the protocol

Study Details

This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.

Key Dates

Start date
Dec 1, 2026
Status verified
May 2026
Primary completion
Sep 30, 2036
Completion
Dec 31, 2036

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose level 1 (Phase I)
    First dose level of etentamig to be explored in combination with Isa-VRd
  • Experimental: Dose Level 2 (Phase I)
    Second dose level of etentamig to be explored in combination with Isa-VRd
  • Experimental: RP2D in Phase II
    RP2D of etentamig to be explored in combination with Isa-VRd

Primary Outcome Measure

Safety and tolerability (Phase I) [ Time Frame: through induction treatment, on average 4 months ]

Central Contacts

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