Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
| Myeloma Multiple | Plasma Cell Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib + Lenalidomide + Dexamethasone | Drug | — | UNRESOLVED |
| Etentamig | Drug | — | UNRESOLVED |
| Isatuximab | Drug | Isatuximab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose level 1 (Phase I)
- description
- First dose level of etentamig to be explored in combination with Isa-VRd
- interventionNames
- Drug: Etentamig
- Drug: Isatuximab
- Drug: Bortezomib + Lenalidomide + Dexamethasone
- type
- EXPERIMENTAL
- label
- Dose Level 2 (Phase I)
- description
- Second dose level of etentamig to be explored in combination with Isa-VRd
- interventionNames
- Drug: Etentamig
- Drug: Isatuximab
- Drug: Bortezomib + Lenalidomide + Dexamethasone
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available