Single-cell Immune Atlas may enable prediction of MM recurrence risk
Dysregulation of the interactions between myeloma cells and the bone marrow microenvironment plays a key role in the pathogenesis and progression of myeloma. Leveraging single-cell RNA-sequencing-based profiling of almost 1.4 million cells from the bone marrow of 337 patients with newly diagnosed myeloma, researchers assembled an Immune Atlas of MM. In the study, published in Nature Cancer, baseline enrichment of specific immune-cell populations was associated with early relapse following treatment.

Novel in vivo CAR-T cell-generating MM therapy granted IND clearance by US FDA
KLN-1010, a novel in vivo gene therapy for generating BCMA-targeted CAR-T cells, was granted Investigational New Drug clearance by the US FDA. Early data from MMyCAR, a first-in-human phase 1 study of KLN-1010 in patients with relapsed/refractory myeloma conducted in Australia, were reported in the Late-Breaking Abstracts Session at the 2025 Annual Society of Hematology Meeting. The IND clearance will allow expansion of the phase 1 trial in the United States.

FDA issues flexible CMC requirements for cell and gene therapies
The US FDA announced reforms of its oversight of the chemistry, manufacturing and control (CMC) requirements for cell and gene therapies, with the intention of expediting therapeutic development. The reforms, under FDA’s new “flexible approach,” encompass changes to clinical development, commercial specifications, and process validation for manufacture of this class of therapies. To date, two cell-based gene therapies—i.e., CAR-T therapies—have been granted regulatory approval for myeloma indications.

Radiolabeled BCMA-targeted nanobody may aid in MM diagnosis and treatment
In a report published in Theranostics, researchers describe the synthesis of a novel BCMA-targeted nanobody—a small antibody fragment tethered to a radioactive isotope. The [¹⁸F]FPy-pyridine–labeled anti-BCMA nanobody demonstrated high BCMA-binding affinity and tumor specificity, as well as higher uptake in BCMA-positive lesions in myeloma models.

Second primary malignancy risk in recipients of T-cell redirecting therapy
Second primary malignancies (SPMs) are potential long-term toxicity concerns associated with anti-cancer therapies, especially in the context of T-cell redirecting therapies. A systematic review, published in Leukemia and Lymphoma, evaluated the risk of SPM in patients with MM who received CAR-T or bispecific antibody therapies. SPM risk was center stage at the session on “Secondary Malignancies and Non-Relapse Mortality,” held during  the 6^th Annual IMS Workshop on Immune Effector Cell Therapies in Multiple Myeloma. A manuscript based on the session is under development.

Impact of melphalan dosing intensity on transplant outcomes
Melphalan at a dose of 200 mg/m² is considered the standard conditioning regimen prior to autologous stem cell transplant in myeloma. Reduced-dose melphalan conditioning is an alternative for older/frail patients. A retrospective analysis conducted in India, reported in Blood Cancer Journal, found comparable survival outcomes in patients who received standard vs reduced-intensity melphalan, except for those with high-risk cytogenetics, bone marrow minimal residual disease-positivity, and PET-positivity before transplant.