Etenta-Isa-VRd in Newly Diagnosed High-Risk Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Etentamig, Isatuximab, Bortezomib + Lenalidomide + Dexamethasone.
- Who it may be relevant to
- Registry conditions: Myeloma Multiple, Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Drug Etentamig
Administered per the protocol - Drug Isatuximab
Administered per the protocol - Drug Bortezomib + Lenalidomide + Dexamethasone
Administered per the protocol
Primary outcome measures
- Safety and tolerability (Phase I) [Time frame: through induction treatment, on average 4 months]
- MRD negativity (Phase II) [Time frame: through consolidation phase completion, an average of 1 year]
- PFS [Time frame: up to 10 years]
Secondary outcome measures (11)
- ORR [Time frame: up to 10 years]
- CR rate [Time frame: up to 10 years]
- VGPR Rate [Time frame: up to 10 years]
- DoR [Time frame: up to 10 years]
- TTR [Time frame: up to 10 years]
- PFS2 [Time frame: up to 10 years]
- OS [Time frame: up to 10 years]
- MRD negativity [Time frame: up to 10 years]
- Sustained MRD [Time frame: up to 10 years]
- MRD-negative CR [Time frame: up to 10 years]
- Sustained MRD-negative CR [Time frame: up to 10 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Medical Center Hamburg-Eppendorf — Hamburg
Identifiers
NCT: NCT07600151 · CONQUISTADOR trial · 2025-523049-83-00