Etenta-Isa-VRd in Newly Diagnosed High-Risk Multiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Etentamig
DrugAdministered per the protocol
Isatuximab
DrugAdministered per the protocol
Bortezomib + Lenalidomide + Dexamethasone
DrugAdministered per the protocol
Treatment groups
220 Participants
are divided into 3 treatment groupsGroup A: Dose level 1 (Phase I)Experimental treatment 3 interventions
Group B: Dose Level 2 (Phase I)Experimental treatment 3 interventions
Group C: RP2D in Phase IIExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Safety and tolerability (Phase I)
Number of dose-limiting toxicities (DLTs) in participants and rates of adverse events (AEs) of grade ≥2 and of severe AEs in participants
Time frame
through induction treatment, on average 4 months2
MRD negativity (Phase II)
MRD-negativity rate after 12 cycles (with a sensitivity of \<10-5)
Time frame
through consolidation phase completion, an average of 1 year3
PFS
Progression-free survival
Time frame
up to 10 yearsSecondary outcomes
1
ORR
Overall response rate
Time frame
up to 10 years2
CR rate
Complete Response Rate
Time frame
up to 10 years3
VGPR Rate
Very good partial response rate
Time frame
up to 10 years4
DoR
Duration of Response
Time frame
up to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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