NCT07600151Not yet recruitingPhase 1
A Clinical Phase I/II, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients
Universitätsklinikum Hamburg-Eppendorf1 site in 1 country220 target enrollmentStarted: December 1, 2026Last updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 220
- Locations
- 1
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
- •Participants must have High-risk myeloma according to IMS/IMWG CGS
- •Participants must be considered a candidate for high-dose chemotherapy and ASCT, as described in the protocol.
- •Participants must have measurable disease as defined in the protocol. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions).
- •Participants must have clinical laboratory values within a prespecified range.
Exclusion Criteria
- •Known contraindications to the use of any IMP or axMP or required concomitant drugs or supportive treatment.
- •known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia
- •Administration of systemic therapy for multiple myeloma except osteoprotective therapy. Emergency myeloma treatment with dexamethasone is allowed according to specifications in the protocol. It is allowed to include patients after 1 cycle of any anti-myeloma first-line treatment within the specifications of the protocol
- •known central nervous system involvement by MM.
Investigators
Study Sites (1)
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