A triplet treatment plus autologous stem-cell transplantation (AHSCT) was associated with longer progression-free survival (PFS) than the triplet treatment alone in patients with newly diagnosed multiple myeloma (MM). However, adding AHSCT to the triplet treatment did not improve five-year survival rates over the triplet alone, according to results from the phase III DETERMINATION trial.
Paul Richardson, MD, of the Dana Farber Cancer Center, and colleagues, conducted the trial and published its results in the New England Journal of Medicine.
All patients received one cycle of lenalidomide, bortezomib, and dexamethasone. Researchers randomly assigned patients in a 1:1 ratio to receive two additional cycles of the triplet treatment plus stem-cell mobilization, followed by five additional cycles of the triplet treatment (n=357), or high-dose melphalan plus AHSCT followed by two additional cycles of the triplet treatment (n=365). Patients in both groups received lenalidomide until disease progression, unacceptable side effects, or both. PFS was the primary endpoint of the study.
The median PFS was higher in the patients receiving the triplet treatment plus AHSCT (67.5 months) than in the patients receiving the triplet treatment alone (46.2 months) at a median follow-up of 76 months.
The risk of disease progression or death was 53% higher in patients receiving the triplet treatment alone (hazard ratio, 1.53; 95% CI, 1.23 to 1.91; P<.001).) However, the five-year survival rates were similar between the groups, with a five-year survival rate of 79.2% for patients receiving the triplet treatment and 80.7% for patients receiving the triplet treatment plus AHSCT.
A partial response or better was reported in 95% of patients receiving the triplet treatment and in 97.5% of patients receiving the triplet treatment plus AHSCT (P=.55). A complete response or better was reported in 42% of patients receiving the triplet treatment and in 46.8% of patients receiving the triplet treatment plus AHSCT (P=.99).
Treatment-related adverse events of grade 3 or higher occurred in 78.2% of patients receiving the triplet treatment and in 94.2% of patients receiving the triplet treatment plus AHSCT.
“Among adults with multiple myeloma, [lenalidomide, bortezomib, and dexamethasone] plus AHSCT was associated with longer progression-free survival than [lenalidomide, bortezomib, and dexamethasone] alone,” the researchers concluded. “No overall survival benefit was observed.”
Richardson PG, Jacobus SJ, Weller EA, et al. Triplet therapy, transplantation, and maintenance until progression in myeloma. N Engl J Med. 2022;387(2):132-147. doi:10.1056/NEJMoa2204925