In patients with high-risk multiple myeloma, maintenance therapy with belantamab, pomalidomide, and dexamethasone (BPD) demonstrated encouraging activity and a manageable safety profile, according to an interim analysis.
Ajay K. Nooka, MD, MPH, FACP, the director of the Myeloma Program and associate director of clinical research at the Winship Cancer Institute of Emory University in Atlanta, led the study and reported the results of the interim analysis during a late-breaking abstract session on September 18, 2025, at the International Myeloma Society (IMS) Annual Meeting in Toronto.
The trial design drew on the DREAMM-8 and ALGONQUIN trials, which established the safety of belantamab in combination regimens, and aimed to evaluate BPD as a post-transplant maintenance option for high-risk disease.
In this analysis, eligible patients carried adverse cytogenetic features, including del(17p), t(4;14), t(14;16), or primary plasma cell leukemia, and were enrolled within six months of autologous transplant after achieving at least a partial response. Patients had to be eligible to receive maintenance therapy.
The phase II study included a safety run-in followed by dose expansion. Belantamab was given at 1.9 mg/kg every 56 days for the first two doses, with the option to extend to every 12 weeks, along with pomalidomide 4 mg on days 1–21 of a 28-day cycle and dexamethasone 40 mg weekly.
The trial included both a safety run-in and dose expansion portion. The primary endpoint was complete response or better and the secondary endpoints included progression-free survival, duration of response, overall survival, and minimal residual disease (MRD) negativity using next-generation sequencing.
Among the first 17 evaluable patients, the rate of complete or stringent complete response increased from 31% at study entry to 68% on treatment. MRD negativity at 10⁻⁶ sensitivity was achieved in 65% of patients overall and in 90% of those with stringent complete responses. With a median follow-up of six months from study entry and 15 months from diagnosis, no progression events were observed.
Dr. Nooka concluded that BPD maintenance is safe, well tolerated, and efficacious in high-risk multiple myeloma.
“The current results support the exploration of BPD maintenance in future high-risk studies,” Dr. Nooka said during the presentation.
Dr. Nooka and colleagues are continuing the study with 20 additional patients following the updated International Myeloma Working Group criteria.
Reference
Nooka AK, Joseph N, Parikh. Maintenance therapy with belantamab, pomalidomide and dexamethasone in high-risk myeloma patients: a phase 2 study with a safety run-in – interim analysis. Abstract OA-66. Presented at the 2025 International Myeloma Society Annual Meeting; September 17-20; Toronto, Canada.
