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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Administered per the protocol
Administered per the protocol
Administered per the protocol
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
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 months
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 year
PFS
Progression-free survival
Time frame: up to 10 years
ORR
Overall response rate
Time frame: up to 10 years
CR rate
Complete Response Rate
Time frame: up to 10 years
VGPR Rate
Very good partial response rate
Time frame: up to 10 years
DoR
Duration of Response
Time frame: up to 10 years
TTR
Time to response
Time frame: up to 10 years
PFS2
Progression free survival 2
Time frame: up to 10 years
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OS
Overall survival
Time frame: up to 10 years
MRD negativity
Minimal Residual Disease (MRD) Negativity Rate (10-5 to 10-6)
Time frame: up to 10 years
Sustained MRD
Sustained MRD negativity rate (for a duration of 6-months, and multiples therof)
Time frame: up to 10 years
MRD-negative CR
Rates of MRD-negative Complete Responses
Time frame: up to 10 years
Sustained MRD-negative CR
Rate of Sustained MRD-negative Complete Response
Time frame: up to 10 years