In a Chinese phase II study (CAREMM-001) reported in the Journal of Clinical Oncology, Yan et al found that B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy was highly active in patients with newly diagnosed multiple myeloma who were ineligible for or did not proceed to autologous stem cell transplantation (ASCT).
Study Details
In the multicenter trial, 36 patients enrolled between April 2023 and December 2024 received three to four cycles of protocol-allowed induction, followed by BCMA CAR T-cell infusion, subsequent consolidation, and lenalidomide maintenance. The primary outcome measure was rate of measurable residual disease (MRD)–negativity (at 10-5) at 3 months after infusion.
Key Findings
MRD negativity at month 3 was observed in all patients (100%, 95% confidence interval [CI] = 90.3%–100.0%). No MRD recurrence was observed during a median follow-up of 15.8 months (range = 4.3–26.0 months) after infusion.
The rate of complete response increased from 33.3% (95% CI = 18.6%–51.0%) prior to infusion to 69.4% (95% CI = 51.9%–83.7%) at month 3 and to 94.4% (95% CI = 81.3%–99.3%) at final follow-up.
The most common grade 3 or 4 adverse events were transient cytopenias, including lymphopenia (100.0%), neutropenia (88.9%), leukopenia (80.6%), thrombocytopenia (19.4%), and anemia (8.3%). Cytokine-release syndrome occurred in 52.8% of patients (all grade 1 or 2); immune effector cell–associated neurotoxicity occurred in 5.6% (all grade 1); and infections were observed in 30.6% (grade ≥ 3 in 19.4%). No death or disease progression was reported.
The investigators concluded: “Frontline BCMA CAR-T therapy induces deep, rapid, and durable remissions with a manageable safety profile in the newly diagnosed multiple myeloma population ineligible for or not proceeding to ASCT. These findings support its investigation as a potentially practice-changing strategy for this population.”
Gang An, MD, PhD, of Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by the Noncommunicable Chronic Diseases–National Science and Technology Major Project, National Natural Science Foundation of China, and others. For full disclosures of the study authors, visit ascopubs.org.
