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Multicenter Study
. 2024 Sep;113(3):310-320.
doi: 10.1111/ejh.14222. Epub 2024 May 9.

Effectiveness and safety of belantamab mafodotin in patients with relapsed or refractory multiple myeloma in real-world setting: The ALFA study

Murielle Roussel  1 , Nathalie Texier  2 , Virginie Nael  2 , Jacopo Bitetti  3 , Prani Paka  3 , Naima Kerbouche  4 , Lynda Sail  4 , Xavier Colin  4 , Xavier Leleu  5
Affiliations
Multicenter Study

Effectiveness and safety of belantamab mafodotin in patients with relapsed or refractory multiple myeloma in real-world setting: The ALFA study

Murielle Roussel et al. Eur J Haematol. 2024 Sep.

Abstract

Objectives: The aim of this noninterventional, retrospective ALFA study was to describe belantamab mafodotin effectiveness and safety in patients with relapsed/refractory multiple myeloma in a real-world setting in France.

Methods: Response rate, progression-free survival (PFS), overall survival (OS), and safety were assessed.

Results: Among the 184 patients initiating belantamab mafodotin treatment, the overall response rate was 32.7% (≥very good partial response [VGPR] 20.4%, partial response [PR] 12.3%). The median PFS (mPFS) was 2.4 months (95% confidence interval [CI]: 1.9, 3.3), and median OS (mOS) was 8.8 months (95% CI: 6.3, 11.6). According to best response, mPFS was 20.6 months (95% CI: 12.1, not reached [NR]) in patients with ≥VGPR and 7.1 months (95% CI: 4.6, 9.4) in patients with PR; mOS was NR in patients with ≥VGPR and 17.5 months (95% CI: 7.7, NR) in patients with PR. For both OS and PFS, no differences were found in subgroups of interest. The adverse events (AEs) reported in 159 patients (86.4%) were mostly ocular AEs.

Conclusions: ALFA, the largest real-world cohort conducted so far, confirms the results of belantamab mafodotin as reported in the DREAMM-2 clinical trial. The clinical benefit is significant as long as the patient is a responder.

Keywords: belantamab mafodotin; multiple myeloma; real‐world evidence; relapsed/refractory.

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References

REFERENCES

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