DREAMM-7
Trial question
What is the role of belantamab mafodotin, bortezomib, and dexamethasone in patients who had a progression of multiple myeloma after at least one line of therapy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 494
494 patients (222 female, 272 male).
Inclusion criteria: patients who had relapsed or refractory multiple myeloma after at least one line of therapy.
Key exclusion criteria: disease refractory to anti-CD38 therapy; exposure to anti-B-cell maturation antigen therapy.
Interventions
N=243 BVd (belantamab mafodotin, bortezomib, and dexamethasone).
N=251 DVd (daratumumab, bortezomib, and dexamethasone).
Primary outcome
Median progression-free survival
36.6 months
13.4 months
36.6 months
27.5 months
18.3 months
9.2 months
0.0 months
BVd
DVd
Significant
increase ▲
Significant increase in median progression-free survival (36.6 months vs. 13.4 months; HR 2.44, 95% CI 1.89 to 3.23).
Secondary outcomes
Significant increase in overall survival at 18 months (84% vs. 73%; HR 1.75, 95% CI 1.25 to 2.5).
Safety outcomes
No significant differences in adverse events, infections and infestations.
Significant difference in ocular events (79% vs. 29%).
Conclusion
In patients who had relapsed or refractory multiple myeloma after at least one line of therapy, BVd was superior to DVd with respect to median progression-free survival.
Reference
Vania Hungria, Pawel Robak, Marek Hus et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):393-407.
Open reference URL