Determination Trial Confirms Importance of Individualizing Therapy for Newly Diagnosed Multiple Myeloma
In the phase 3 DETERMINATION trial—in which patients with newly diagnosed multiple myeloma were randomly assigned to a standard triplet regimen with and without autologous stem-cell transplantation (ASCT), with all receiving lenalidomide (Revlimid) maintenance therapy until disease progression—patients with ASCT had significantly longer progression-free survival (PFS) versus those who did not, but no difference in overall survival (OS) was observed between the 2 treatment arms.
IKEMA is an ongoing, phase 3, randomized, open-label, parallel-group study that reached its interim analysis milestone. The study evaluated the effect of adding isatuximab (Isa) to carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM).
In Patients with RRMM, Idecabtagene Vicleucel, a BCMA-Directed CAR T-Cell Therapy: CRB-401 Study Updates
In patients with relapsed/refractory multiple myeloma (RRMM) at target dose levels of ≥150 × 106 chimeric antigen receptor (CAR)+ T-cells, the updated analysis of the phase 1 CRB-401 study supports a favorable clinical benefit–risk profile for the B-cell maturation antigen (BCMA)-directed CAR T-cell therapy, idecabtagene vicleucel.
CARTITUDE-1: In Patients with RRMM, Ciltacabtagene Autoleucel, a BCMA-Directed Chimeric Antigen Receptor T-Cell Therapy
In heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM), preliminary results from the phase 1b/2 CARTITUDE-1 study show early, deep, and durable responses with a single low-dose infusion of ciltacabtagene autoleucel (cilta-cel) and a safety profile consistent with prior studies.
Favorable efficacy and manageable safety are shown in the updated analysis of the phase 1 study of teclistamab in patients with relapsed/refractory multiple myeloma (RRMM). This analysis supports the planned phase 2 monotherapy trial at 1500 µg/kg administered subcutaneously.
In Patients with RRMM, REGN5458, a BCMA × CD3 Bispecific Monoclonal Antibody, Induces Deep and Durable Responses
This phase 1, first-in-human study evaluates patients with relapsed/refractory multiple myeloma (RRMM) who are heavily pretreated with REGN5458. Results of this updated analysis are consistent with those of previous findings showing an acceptable safety profile and deep and durable responses. The phase 2 portion of the study is further progressing.
APOLLO: In Patients with RRMM, Daratumumab plus Pomalidomide and Dexamethasone versus Pomalidomide and Dexamethasone Alone
This primary analysis evaluated patients with relapsed/refractory multiple myeloma (RRMM) who had received ≥1 prior lines of therapy, including lenalidomide (Len) and a proteasome inhibitor (PI). Compared with pomalidomide and dexamethasone (Pd) alone, daratumumab (DARA) plus Pd reduced the risk of disease progression and death without additional safety signals.
Patients who were non–transplant eligible, newly diagnosed with multiple myeloma (NDMM) and frail have inferior overall survival (OS), primarily because of treatment discontinuation due to toxicity. Therefore, evaluation of less-toxic effective therapies, such as the oral proteasome inhibitor ixazomib (Ixa) and the monoclonal anti-CD38 antibody daratumumab (Dara), is critical for this patient population as well as the elderly.
CANDOR Study: Subgroup Analysis of Carfilzomib and Dexamethasone with or without Daratumumab in RRMM
The CANDOR trial was a randomized, open-label, phase 3 study in which carfilzomib, dexamethasone, and daratumumab were compared with carfilzomib and dexamethasone (Kd) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who had undergone 1 to 3 prior lines of therapy.
In patients with relapsed/refractory multiple myeloma (RRMM), although promising efficacy and acceptable toxicity were reported for belantamab mafodotin plus pomalidomide and dexamethasone, the high dose rate holds at the 2.5-mg/kg dose level were deemed to warrant examination of alternative-dosing schedules.