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Triplet Regimen Plus AHSCT Boosts PFS in Adults with MM

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In patients with newly diagnosed multiple myeloma (MM), the addition of autologous hematopoietic stem cell transplant (AHSCT) to a triplet regimen of lenalidomide, bortezomib, and dexamethasone with lenalidomide maintenance resulted in significantly better progression-free survival (PFS) versus those who did not receive AHSCT, according to the phase III DETERMINATION trial.

Although PFS was significantly better, the results of the trial, which were published in The New England Journal of Medicine, showed no difference in overall survival (OS).

A total of 357 patients (aged 18 to 65 years) with symptomatic MM were randomly assigned to arm A (without AHSCT; 57% male; median age, 57 years) and 365 patients were assigned to arm B (with AHSCT; 59% male; median age, 55 years). Both arms received two additional cycles of the regimen plus stem cell mobilization, followed by either five additional cycles (arm A) or high-dose melphalan plus AHSCT followed by two additional cycles (arm B). Both groups received lenalidomide until disease progression, unacceptable side effects, or both.

In the primary endpoint analysis, significantly longer median PFS was observed in patients with AHSCT (67.5 months) compared with those without AHSCT (46.2 months; hazard ratio [HR], 1.53; 95% CI, 1.23-1.91; P<.0001). Five-year OS was similar between the two arms (HR, 1.10; 95% CI, 0.73-1.65; P=.99).

The median duration of lenalidomide maintenance was 36.4 months in the non-AHSCT arm and 41.5 months in the AHSCT arm.

The authors also noted the trial had a high representation of Black participants (approximately 19% of patients), which is “above any other phase III trial in this setting,” Paul G. Richardson, MD, of the Dana-Farber Cancer Institute, said in a statement. “That to us was incredibly gratifying to see.”

The results of the trial suggest that AHSCT, which has traditionally been thought of as a frontline treatment approach, can be used more flexibly than previously thought in terms of treatment timing and sequencing.

“There are a number of important messages from this study that will inform practice,” Dr. Richardson said. “The most important overarching one is that one size doesn’t fit all. This is incredibly exciting for patients because it means you can choose your therapy with a degree of confidence that it won’t necessarily have an impact on your OS.”

Richardson PG, Jacobus SJ, Weller EA, et al. Triplet therapy, transplantation, and maintenance until progression in myeloma. N Engl J Med. 2022. doi:10.1056/NEJMoa2204925

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