Final DREAMM-3 Phase 3 Findings: Belantamab Mafodotin Compared With Pomalidomide Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma

By
Meletios Athanasios Dimopoulos
Vania Hungria
Haitao Meng
Atanas Radinoff
Jian Li
Sosana Delimpasi
Ting Niu
Gabor Mikala
Tamas Masszi
Marcelo Capra
Michael Low
Angelo Maiolino
Yan Xu
Xavier Leleu
Vasiliki Pappa
Dominik Chraniuk
Tatiana Konstantinova
Iurii Osipov
Shawn Hakim
Chris Brawley
Gabriela Tubel
Astrid McKeown
Julia Boyle
Sumita Roy-Ghanta
Katja Weisel
October 17, 2026

Blood Cancer Journal

Objective:

Report final long-term efficacy and safety results for belantamab mafodotin monotherapy versus pomalidomide-dexamethasone in relapsed or refractory multiple myeloma.

Approach:

Design: Multicenter, open-label phase 3 trial; 325 patients were randomized 2:1 to belantamab mafodotin (n=218) or pomalidomide-dexamethasone (n=107).
Analysis: Final descriptive analysis was conducted April 22, 2025. Median follow-up was 22.2 and 21.9 months, respectively; no formal hypothesis testing was prespecified.
Outcomes: Efficacy assessments included PFS, OS, response, duration of response, and PFS2. Safety assessments included adverse events and ophthalmic examination findings.

Key Findings:

Median PFS was 11.2 months with belantamab mafodotin and 7.0 months with pomalidomide-dexamethasone (HR 0.87; 95% CI 0.64–1.18).
Median OS was 24.0 versus 22.9 months (HR 0.98; 95% CI 0.73–1.30).
Median duration of response was 25.3 versus 9.9 months; median PFS2 was 17.3 versus 13.0 months.
Stringent complete response rates were 9% versus 3%; complete response or better with MRD negativity occurred in 8% versus less than 1%.
At least one Grade 3–4 adverse event occurred in 71% of belantamab mafodotin recipients and 66% of pomalidomide-dexamethasone recipients. Blurred vision was reported in 48% and 7%, respectively.
Among belantamab mafodotin recipients with available assessments, sponsor-derived any-grade ophthalmic findings occurred in 133/168 (79%); 107/133 (80%) were Grade 2 or higher. Of patients with an initial Grade 2+ finding, 98/122 (80%) had resolution to Grade …

Interpretation:

The final descriptive analysis reported longer median PFS, duration of response, and PFS2 with belantamab mafodotin, while median OS was similar between groups. The primary endpoint had not met its prespecified superiority threshold, and this final analysis did not include formal hypothesis testing.

Limitations:

The final analysis was descriptive, with no formal hypothesis testing prespecified.
The supplied article context ends during the ophthalmic safety results, so subsequent findings are unavailable.

Sources:

Article context supplied in the prompt

Final DREAMM-3 Phase 3 Findings: Belantamab Mafodotin Compared With Pomalidomide Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma

Objective:

Approach:

Key Findings:

Interpretation:

Limitations:

Sources:

Original Source(s)

Final analysis results from DREAMM-3, a phase 3 study of belantamab mafodotin versus pomalidomide plus dexamethasone in patients with relapsed/refractory multiple myeloma

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