Myeloma
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Oct 05 – Oct 12, 2026
MK-4002, a B-cell maturation antigen-targeting T-cell engager, in relapsed or refractory multiple myeloma: a first-in-human, open-label, phase 1 study.
LANCET HAEMATOL · Q1 JOURNAL - RANK #3/98TOP-TIER
This first-in-human, open-label, phase 1 trial evaluated the trispecific BCMA-targeting T-cell engager MK-4002 in 97 patients with relapsed or refractory multiple myeloma across 12 sites. Using a dose-escalation design (0.005–24 mg weekly or every 2 weeks), the study assessed safety, pharmacokinetics, and overall response rate (ORR) as primary and key secondary endpoints. Dose-limiting toxicities occurred in six patients, cytokine release syndrome in 30%, and ORR was 41% (2.15–6 mg), 63% (12 mg), and 48% (24 mg); the 12 mg dose was identified as the preliminary recommended phase 2 dose. MK-4002 demonstrated manageable safety and clinical activity in heavily pretreated patients, supporting further evaluation at 12 mg.
10.1016/S2352-3026(26)00228-0
Sep 28 – Oct 05, 2026
Linvoseltamab outcomes by frailty status in patients with relapsed/refractory multiple myeloma: a subgroup analysis of the LINKER-MM1 study.
BLOOD CANCER J · Q1 JOURNAL - RANK #24/326TOP-TIER
This post hoc subgroup analysis of the LINKER-MM1 prospective clinical trial evaluated linvoseltamab 200 mg in 117 patients with relapsed/refractory multiple myeloma, categorized by frailty using three measures. The study reported objective response rates and Grade 3/4 treatment-emergent adverse events across frail and non-frail groups over a median follow-up of 21.3 months. Response rates ranged from 62.5% to 74.2% in frail patients and 69.8% to 73.0% in non-frail patients, with consistent safety profiles. The authors conclude that linvoseltamab demonstrates a favorable risk-benefit profile in frail patients, warranting continued evaluation in clinical trials and real-world settings.
10.1038/s41408-026-01572-1
Felzartamab plus lenalidomide-dexamethasone versus lenalidomide-dexamethasone for relapsed or refractory multiple myeloma: an open-label, parallel-controlled, randomised, phase 3 trial.
LANCET HAEMATOL · Q1 JOURNAL - RANK #3/98TOP-TIER
This open-label, parallel-controlled, randomised phase 3 trial evaluated felzartamab plus lenalidomide-dexamethasone versus lenalidomide-dexamethasone in 295 Chinese adults with relapsed or refractory multiple myeloma. Patients were randomised 2:1 to receive felzartamab (16 mg/kg intravenously) plus lenalidomide-dexamethasone (n=195) or lenalidomide-dexamethasone alone (n=100), with progression-free survival as the primary endpoint. At median follow-up of 34.5 vs 28.7 months, median progression-free survival was 18.9 vs 10.4 months (HR 0.62, 95% CI 0.45-0.86; p=0.0035). Felzartamab plus lenalidomide-dexamethasone significantly prolonged progression-free survival, supporting this combination as a potential new treatment option, though grade 3-4 adverse events and treatment-related deaths were more frequent with felzartamab.
10.1016/S2352-3026(26)00223-1
Forimtamig, a GPRC5DxCD3 bispecific antibody with a novel 2:1 format, in relapsed/refractory multiple myeloma.
BLOOD ADV · Q1 JOURNAL - RANK #13/98
This Phase 1 prospective clinical trial evaluated subcutaneous forimtamig, a novel GPRC5DxCD3 bispecific antibody with a 2:1 configuration, in 171 patients with relapsed/refractory multiple myeloma. The study employed dose-escalation followed by backfilling at optimized target doses using weekly and condensed step-up schedules to assess safety, tolerability, and determine the maximum tolerated dose and recommended Phase 2 dose. Dose-limiting toxicities occurred in 11.7% of patients, cytokine release syndrome in 75.4%, and the maximum tolerated dose was not identified, with dose-escalation concluding at 7.2 mg due to accumulating toxicity. The overall response rate was 59.6%, reaching 71.7% with the condensed schedule at optimized doses, demonstrating potent activity but a narrow therapeutic window due to on-target off-tumor toxicities.
10.1182/bloodadvances.2026020498
Induction and extended consolidation with daratumumab, cyclophosphamide, bortezomib, lenalidomide, and dexamethasone in patients with high-risk multiple myeloma (OPTIMUM/MUKnine): 5-year follow-up of a multicentre, externally controlled, phase 2 trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This multicentre, externally controlled, phase 2 trial (OPTIMUM/MUKnine) evaluated intensified induction, extended consolidation, and maintenance therapy with daratumumab, cyclophosphamide, bortezomib, lenalidomide, and dexamethasone in 107 patients with newly diagnosed high-risk multiple myeloma across 22 UK centres. At 5-year follow-up, median progression-free survival was not reached versus 24.4 months in the external control cohort (HR 0.32, 95% CI 0.22-0.45; p<0.0001), and overall survival was also not reached versus 57.4 months (HR 0.43, 95% CI 0.28-0.65; p<0.0001). Progression-free survival 2 was not reached versus 43.9 months (HR 0.26, 95% CI 0.17-0.41; p<0.0001), with consistent benefit across most high-risk subgroups. The authors conclude that risk-stratified extended therapy shows sustained survival improvement, supporting molecular diagnostics and tailored treatment in high-risk multiple myeloma.
10.1016/S1470-2045(26)00286-X
Sep 21 – Sep 28, 2026
Phase 1 Study of Anito-cel, a d-Domain BCMA CAR T Cell for Refractory or Recurrent Myeloma.
NEW ENGL J MED · Q1 JOURNAL - RANK #2/332TOP-TIER
This phase 1 study evaluated anito-cel, a BCMA-directed CAR T-cell therapy with a d-domain binder, in 38 patients with relapsed or refractory multiple myeloma who had received ≥3 prior lines or were triple-class refractory. Patients received dose level 1 (100×10^6 CAR+ T cells) or dose level 2 (300×10^6 CAR+ T cells), with primary endpoints of adverse events and recommended phase 2 dose determination. All 38 patients responded (79% complete response), median progression-free survival was 30.2 months, and grade ≥3 cytokine release syndrome or ICANS occurred in only 1 patient (3%). The authors conclude that anito-cel produced high response rates with rare severe cytokine release syndrome and neurotoxicity in heavily pretreated multiple myeloma.
10.1056/NEJMoa2603527
Aug 31 – Sep 07, 2026
Inflammatory bone marrow microenvironment impairs the therapeutic effect of daratumumab-lenalidomide in multiple myeloma.
BIOMARK RES · Q1 JOURNAL - RANK #12/195TOP-TIER
This study analyzed pre-treatment bone marrow samples from 21 patients in the IFM2017-03 phase 3 trial using single-cell and bulk multiomics to identify determinants of response to daratumumab-lenalidomide in multiple myeloma. The bone marrow microenvironment in non-responders exhibited an inflammatory state with upregulated NF-κB signaling in monocytes, increased proinflammatory ISG+ T cells, and reduced NK cell CD16 expression, alongside enhanced NF-κB activation in myeloma cells. An eight-gene NF-κB-related signature predicted treatment response in independent bone marrow (n=28, AUC=0.81) and peripheral blood (n=40, AUC=0.77) samples. The study concludes that an NF-κB-associated inflammatory axis underlies poor DR response and suggests targeting inflammatory pathways as a potential therapeutic avenue.
10.1186/s40364-026-00992-2
Aug 24 – Aug 31, 2026
MYC rearrangement improves the predictive efficacy of the double-hit model in newly diagnosed multiple myeloma.
ESMO OPEN · Q1 JOURNAL - RANK #36/326
This prospective study evaluated the prognostic impact of MYC rearrangement (MYC-R) and gain/amp in 227 newly diagnosed multiple myeloma patients enrolled in the NICHE clinical trial (NCT04645199), who received bortezomib-based induction and eligible upfront autologous stem cell transplantation. FISH analysis was performed for multiple abnormalities including MYC break-apart and IgH/MYC fusion probes. Results showed significantly shorter median progression-free survival (PFS) for MYC-R (34.0 months) and MYC gain/amp (34.3 months) versus no abnormalities (49.2 months; P=0.003 and 0.016). MYC-R independently predicted PFS (HR 1.96, P=0.007) and improved double-hit model concordance index from 0.549 to 0.581, supporting its integration into risk stratification.
10.1016/j.esmoop.2026.108339