What does this research mean for the field?

In transplant-ineligible newly diagnosed multiple myeloma, the BVRd regimen yields high response rates, with higher belantamab mafodotin induction dose intensity optimizing deep responses and lower maintenance dose intensity improving tolerability and patient-reported outcomes. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This analysis aims to evaluate the safety and efficacy of BVRd in transplant-ineligible patients with newly diagnosed multiple myeloma.

May 29, 2026

DREAMM-9 final analysis: Belantamab mafodotin (belamaf), bortezomib, lenalidomide, and dexamethasone (BVRd) for transplant-ineligible (TI) newly diagnosed multiple myeloma (NDMM).

Puntos clave

This analysis aims to evaluate the safety and efficacy of BVRd in transplant-ineligible patients with newly diagnosed multiple myeloma.
Patients received BVRd across different dosing cohorts: Q3/4W, Q6/8W, Q9/12W, and Q12W.
Safety, overall response rates, and patient-reported outcomes were assessed, with a focus on minimal residual disease negativity.
Median dose intensities were calculated for both induction and maintenance phases.
Overall response rates were ≥83% across all dosing cohorts.
Higher induction median dose intensities were associated with deeper responses, showing CR+/MRD[-] rates of 75/55% in pooled SHORT+STRETCH cohorts vs. 59/43% in pooled Q9/12W+Q12W.
Grade ≥2 ophthalmic exam findings occurred in 90% for pooled SHORT+STRETCH cohorts, with lower rates of grade 3/4 findings in longer dosing intervals.

Resumen

7503 Background: DREAMM-9 (NCT04091126) was a phase 1 dose and schedule evaluation study of BVRd in adults with TI NDMM. Methods: Patients (pts) received BVRd in 1 of 8 belamaf dosing cohorts at an induction/maintenance schedule of Q3/4W (SHORT: 1.9, 1.4, 1.0 mg/kg), Q6/8W (STRETCH: 1.9, 1.4 mg/kg), Q9/12W (step-down S/D: 1.9 for 1 dose then 1.4 mg/kg; 1.4 for 1 dose then 1.0 mg/kg), or Q12W (1.0 mg/kg). The primary endpoint was safety. Responses, minimal residual disease negativity (MRD-) in complete response or better (CR+), and pt-reported outcomes (PROs) were assessed. Median dose intensities (mDIs) were calculated as mg/kg/21 days in induction and mg/kg/28 days in maintenance. Results: As of June 2, 2025, 118 pts were enrolled (intention-to-treat population). Median duration of follow-up was 15.9–47.1 months. Induction mDI generally decreased as planned dosing intervals increased and was lowest in S/D Q9/12W or Q12W cohorts. Maintenance mDI was similar across cohorts due to dose modifications. Overall response rates were ≥83% across cohorts. Cohorts with higher induction mDI had the deepest responses (CR+/MRD- 75/55% for pooled SHORT+STRETCH and 59/43% for pooled Q9/12W+Q12W). Grade (Gr) ≥2 ophthalmic exam findings (OEFs; best-corrected visual acuity changes/slit lamp findings Keratopathy and Visual Acuity scale) were 90% for pooled SHORT+STRETCH/69% for pooled Q9/12W+Q12W, while Gr 3/4 OEF rates were higher with higher induction mDI (79%/35%). Most cohorts (5/8) had no belamaf discontinuations due to Gr ≥3 OEFs, which occurred only in SHORT cohorts (n = 1 each). First Gr ≥2 OEFs resolved prior to end of treatment in 83–100% across cohorts. The long-interval group (Q9/12W and Q12W dosing schedules) remained largely below the vision-related function (VRF) deterioration threshold (12.5 points per Ocular Surface Disease Index) across most timepoints, suggesting a favorable VRF profile vs the SHORT interval group. Conclusions: BVRd had high response rates across all cohorts (≥83%), highlighting the promising efficacy of the regimen. Regimens with higher belamaf induction mDI had the deepest responses, while those with lower induction mDI had milder OEFs. Belamaf dosing with a higher induction DI is optimal to achieve deeper responses, and a lower maintenance DI (i.e., using longer schedules) improves tolerability, PROs, and maintains responses. Clinical trial information: NCT04091126 .

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