This trial is currently open and accepting patients.
This is an open label phase II study that will enroll patients with relapsed and refractory multiple myeloma after four or more lines of therapy who received idecabtagene vicleucel as standard of care.
The research involves study visits and receiving the study drug. Participants will receive the study drug, elranatamab, for up to 6 months and will be followed for as long as they remain in the study, until confirmed progressive disease (disease worsening), or until initiation of other myeloma treatment.
Elranatamab is a type of antibody (a protein produced by the body's immune system when it detects harmful substances) that works by binding to both T-cells (part of the immune system) and myeloma cells. The drug then activates T-cells to kill the myeloma cells. In this study we are researching whether multiple myeloma progresses after elranatamab administration. The U.S. Food and Drug Administration (FDA) has not approved elranatamab as a treatment for any disease.
It is expected that about 32 people will take part in this research study.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Phase 2
Enrollment: 32 patients (estimated)
View MoreSeptember 26, 2026
Results: 25 pts had started Elra consolidation at a median of 3.8 months from ide-cel (range, 3.0-5.2 mo); 23 pts had completed at least one cycle. The median age was 67 (range, 48-82). Seven pts (28%) had high-risk cytogenetics [defined by t(4;14), t(14;16), or del(17p)] and 4 pts (16%) had a history of extramedullary disease. The median number of prior LOTs was 3 (range, 2-6). 13 pts (52%) received Elra step-up dosing as an outpatient.
With a median follow-up of 9.8 months from Elra initiation (range, 1.8 - 22.6 mo), the median PFS has not yet been reached. 6 pts (26%) so far have had an ongoing response over 12 months. Only 1 patient has had PD with a cutaneous plasmacytoma not requiring systemic therapy. Of the pts who had completed at least one cycle of Elra, 61% (n=14/23) started Elra with best response of ≤VGPR post-ide-cel (SD: n=2, PR: n=9, VGPR: n=3, CR/sCR: n=9). 100% of the pts with ≤VGPR post-ide-cel (n=14/14) had deepening of their IMWG response. The best overall response after Elra among the 23 evaluable pts was CR/sCR in 83% (n=19/23) and VGPR in 17% (n=4/23). 11 pts had evaluable MRD samples at screening and after completing or stopping Elra consolidation. Five pts (45%) had conversion from MRD-positivity to MRD-negativity at 10-6 sensitivity and 5 pts (45%) remained MRD-negative from screening through Elra completion; one pt lost MRD-negativity after stopping Elra.
CRS occurred in 11 pts (44%), predominately grade (Gr) 1 with 2 pts (8%) having Gr 2 CRS. No ICANS occurred. Gr 3 or 4 hematologic AEs occurred in 11 pts (44%; neutropenia: n=10, 40%, anemia: n=4, 16%, thrombocytopenia: n=3, 12%). Gr 3 or 4 non-hematologic AEs occurred in 9 pts (36%). Infections occurred in 14 pts (56%) with Gr 3 or 4 infections in 5 pts (20%). CMV viremia occurred in 6 pts (24%), with only 1 pt requiring CMV-directed treatment while the other 5 pts had resolution of CMV viremia without intervention. All patients received IVIG.
Conclusions: Fixed-duration consolidation after ide-cel with Elra led to deepening of disease responses and MRD-conversion with ongoing, durable responses observed. The EPIC trial is fully accrued and updated data will be presented.
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