NCT07600151Not yet recruitingPhase 1/2
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 · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 26 Apr 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Sept 2036
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Diseases
- Multiple myeloma
- NCT number
- NCT07600151
- EU CT number
- 2025-523049-83-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 220
- From 1 Dec 2026 to the primary completion date, 30 Sept 2036
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia
Other
- known central nervous system involvement by MM.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.