IFM2017-03: Daratumumab therapy fruitful for frail patients with MM

Daratumumab plus lenalidomide resulted in superior progression-free survival (PFS) outcomes compared with lenalidomide plus dexamethasone in frail patients with previously untreated multiple myeloma (MM). The safety profile of the experimental treatment regimen was favourable.

The phase 3 IFM2017-03 trial (NCT03993912) randomised 295 frail patients (based on ECOG proxy frailty assessment) of at least 65 years of age with newly diagnosed MM 2:1 to daratumumab plus lenalidomide or lenalidomide plus dexamethasone [1]. The primary endpoint of the trial was PFS.

After a median follow-up of 46.3 months, the daratumumab group outperformed the dexamethasone group in terms of median PFS (53.4 vs 22.5 months; HR 0.51; 95% CI 0.37–0.70; P<0.0001). “This represents a 49% reduction in the risk of progression or death for participants on daratumumab,” said Prof. Salomon Manier (University of Lille, France). Similarly, the median overall survival was significantly longer in the daratumumab group than in the dexamethasone group (not reached vs 47.2 months; HR 0.52; 95% CI 0.35–0.77; P=0.0001).

Grade 3 or higher neutropenia (55% vs 24%), anaemia (12% vs 3%), and thrombocytopenia (10% vs 5%) were more frequently observed in the daratumumab arm. “There were no differences between the study arms concerning infections or treatment discontinuations,” added Prof. Manier.

“The phase 3 IFM2017-03 trial demonstrated that a dexamethasone-sparing strategy is efficacious and safe for the treatment of frail patients with previously untreated MM,” decided Prof. Manier.

1. Manier S, et al. A dexamethasone sparing regimen with daratumumab and lenalidomide in frail patients with newly diagnosed multiple myeloma: the phase 3 IFM2017-03 trial. Abstract 774, 66^th ASH Annual Meeting, 7–10 December 2024, San Diego, CA, USA.

Medical writing support was provided by Robert van den Heuvel.

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Posted on 12 December 202412 December 2024