IMS/IMWG definition of high-risk myeloma validated in over 6,500 newly diagnosed patients
The IMS-IMWG consensus genomic definition for high-risk multiple myeloma (HRMM), based on the 2023 IMS Genomic Meeting, was published in the Journal of Clinical Oncology in July 2025. Researchers in France validated the HRMM definition in a contemporary cohort of 6,528 newly diagnosed patients and 1583 at first relapse, diagnosed in/after 2019. In a commentary that accompanies the report in Blood, authors make the case for adoption of next-generation sequencing-based genomic profiling in myeloma practice.

US FDA issues Draft Guidance for MRD use as a regulatory endpoint in MM approvals
In April 2024, the US FDA’s Oncologic Drugs Advisory Committee (ODAC) issued a unanimous vote in favor of allowing sponsors to use MRD assessment as an endpoint in the regulatory framework of multiple myeloma (MM) treatments. This decision has now been translated into a Draft Guidance document, detailing the use of MRD and complete response as primary efficacy endpoints in clinical trials supporting accelerated approval of MM therapies.

Tracking the evolving landscape of smoldering multiple myeloma
In November 2025, the US FDA approved the first-ever treatment for adults with high-risk smoldering multiple myeloma (SMM), based on the AQUILA study. SMM management is in a transformative period; a manuscript outlining IMS-IMWG consensus recommendations for diagnosis, risk stratification, and management of SMM is under development. A review published in Nature Reviews Clinical Oncology explores these topics.

Early-phase trials demonstrate promising efficacy of emerging CAR-T therapies
Long-term results from the single-arm phase 1/2 LUMMICAR study of zevorcabtagene autoleucel, a fully human anti-BCMA CAR-T therapy, showed an objective response rate (ORR) of 100. These findings, reported in Blood Advances, were previously presented at the 2025 IMS Annual Meeting. Phase 1 findings for another BCMA-directed CAR-T therapy—bb21217, manufactured under conditions that enrich for T-cells with a memory-like phenotype—demonstrated an ORR of 69.4%, according to a report in Cancer Immunology Research.

A potential new radioimmunotherapy approach in MM
A report published in Clinical Cancer Research describes a new radioimmunotherapy approach—a CD48-targeted antibody-drug conjugate that is either co-administered with a radio-labeled antibody or coupled with a radiolabeled payload. This new radioimmunotherapy exhibited preclinical anti-tumor activity in prostate cancer and MM.

 Time of day of receipt of BCMA CAR-T therapies may not affect short-term outcomes  
In a retrospective study published in JCI Insight, early morning CAR-T cell infusions correlated with improved survival and lower rates of severe neurotoxicity in 715 patients who received CD19- or BCMA-targeted CAR-T therapies. However, there were no significant differences in 90-day overall survival among patients with MM who received BCMA CAR-T therapies between those who received early morning vs late evening infusions.