A phase 2 trial of abbreviated fixed-duration (Default 4 Cycles) linvoseltamab immunoconsolidation to deepen responses post newly diagnosed multiple myeloma combination therapy for minimal residual disease positivity (the IMMUNOPLANT Study)
As of July 23, 2025 (data cut-off), 19 patients (median follow up: 3.9 months) were enrolled with a median age of 60 years (range: 40-77) including 26% female; 11% Black, 47% Hispanic; 74% ECOG PS 0, 26% 1; 47% IgG, 21% IgA, 32% light chain only; 32% high-risk FISH (53% standard, 16% unknown). Prior to study entry, median combination cycles was 8 (range: 6-13) and 42% received KRd, 26% D-VRd, 21% DKRd, 5% DRd, and 5% Isa-VRd. All patients were clonoSEQ MRD positive (84% VGPR; 16% sCR). As of data cut-off, 14 patients completed 4 cycles of Linvo and underwent MRD assessment with 100% (95%CI: 76.8- 100%) achieving MRD negativity by both NGS clonoSEQ (10 -6 ) and flow cytometry (10 -5 ) (13 sCR; 1 VGPR). All patients remain alive, with no relapses and all after C4 have initiated lenalidomide-based maintenance therapy per treating physician. All 3 patients who reached the 6-month post Linvo MRD milestone remain MRD negative. Of the 19 patients who received Linvo to date, no patients developed any grade CRS or ICANS. Any grade adverse event (AE) occurred in 84% (74% Linvo related). Any grade related AEs occurring in >1 patient included: upper respiratory infection (3), rash (3), bone pain (2), cough (2), and neutropenia (2). Grade 3 AEs included neutropenia in 1 patient and infection (peritonsillar abscess) in another which was a serious AE (SAE). No other SAEs nor Grade 4 or 5 AEs occurred.