Daratumumab-based quadruplet therapy for transplant-eligible newly diagnosed multiple myeloma with high cytogenetic risk.
СтатьяПоддержка исследования: вне правительства СШАРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Callander Natalie S, Silbermann Rebecca, Kaufman Jonathan L, Godby Kelly N, Laubach Jacob, Schmidt Timothy M, Sborov Douglas W, Medvedova Eva, Reeves Brandi, Dhakal Binod, Rodriguez Cesar, Chhabra Saurabh, Chari Ajai, Bal Susan, Anderson Larry D, Dholaria Bhagirathbhai R, Nathwani Nitya, Hari Parameswaran, Shah Nina, Bumma Naresh, Holstein Sarah A, Costello Caitlin, Jakubowiak Andrzej, Wildes Tanya M, Orlowski Robert Z, Shain Kenneth H, Cowan Andrew J, Pei Huiling, Cortoos Annelore, Patel Sharmila, Lin Thomas S, Giri Smith, Costa Luciano J, Usmani Saad Z, Richardson Paul G, Voorhees Peter M
Аннотация
In the MASTER study (NCT03224507), daratumumab+carfilzomib/lenalidomide/dexamethasone (D-KRd) demonstrated promising efficacy in transplant-eligible newly diagnosed multiple myeloma (NDMM). In GRIFFIN (NCT02874742), daratumumab+lenalidomide/bortezomib/dexamethasone (D-RVd) improved outcomes for transplant-eligible NDMM. Here, we present a post hoc analysis of patients with high-risk cytogenetic abnormalities (HRCAs; del[17p], t[4;14], t[14;16], t[14;20], or gain/amp[1q21]). Among 123 D-KRd patients, 43.1%, 37.4%, and 19.5% had 0, 1, or ≥2 HRCAs. Among 120 D-RVd patients, 55.8%, 28.3%, and 10.8% had 0, 1, or ≥2 HRCAs. Rates of complete response or better (best on study) for 0, 1, or ≥2 HRCAs were 90.6%, 89.1%, and 70.8% for D-KRd, and 90.9%, 78.8%, and 61.5% for D-RVd. At median follow-up (MASTER, 31.1 months; GRIFFIN, 49.6 months for randomized patients/59.5 months for safety run-in patients), MRD-negativity rates as assessed by next-generation sequencing (10-5) were 80.0%, 86.4%, and 83.3% for 0, 1, or ≥2 HRCAs for D-KRd, and 76.1%, 55.9%, and 61.5% for D-RVd. PFS was similar between studies and superior for 0 or 1 versus ≥2 HRCAs: 36-month PFS rates for D-KRd were 89.9%, 86.2%, and 52.4%, and 96.7%, 90.5%, and 53.5% for D-RVd. These data support the use of daratumumab-containing regimens for transplant-eligible NDMM with HCRAs; however, additional strategies are needed for ultra-high-risk disease (≥2 HRCAs). Video Abstract.