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

Not Yet RecruitingPhase 1, Phase 2

Sponsor: Universitätsklinikum Hamburg-Eppendorf

Conditions: Myeloma Multiple, Myeloma

Interventions: Etentamig, Isatuximab, Bortezomib + Lenalidomide + Dexamethasone

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Hamburg, Germany