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

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 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.