Etenta-Isa-VRd in Newly Diagnosed High-Risk Multiple Myeloma
Key facts
- Where
- Hamburg, GermanySee the site
- Phase
- Phase 1/2
Where in Germany
- University Medical Center Hamburg-EppendorfHamburg, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitätsklinikum Hamburg-Eppendorf
- Trial code
- NCT07600151EU 2025-523049-83-00
- Record updated
- 20 May 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Known contraindications to the use of any IMP or axMP or required concomitant drugs or supportive treatment; 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 systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia; known central nervous system involvement by MM.