ASH 2023: Four Drugs, Two Transplants, One Study’s Results in High-Risk Myeloma

By: Celeste L. Dixon
Posted: Monday, December 11, 2023

An intensive treatment strategy—six induction cycles of daratumumab plus the triplet of carfilzomib, lenalidomide, and dexamethasone; autologous stem cell transplantation (ASCT); four consolidation cycles of daratumumab plus the triplet; a second ASCT; and maintenance with daratumumab and lenalidomide for 2 years—is feasible in patients with newly diagnosed, previously untreated, transplantation-eligible multiple myeloma who have a high-risk cytogenetic profile. The strategy resulted in high rates of measurable residual disease (MRD) negativity and progression-free survival, according to the final results of the phase II IFM 2018-04 study. In this population, high-risk cytogenetics are associated with poor outcomes, noted Cyrille Touzeau, MD, PhD, of Centre Hospitalier Universitaire de Nantes, France, and colleagues, who presented their work during the 2023 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 207).

A total of 50 participants (median age, 57 years) were treated between July 2019 and March 2021 in 11 Intergroupe Francophone du Myelome centers. At data cutoff, the study had met its primary endpoint of feasibility, with 36 patients (72%) completing their second transplantation.

High-risk disease was defined as the presence of 17p deletion (n = 20), t(4;14; n = 26), and/or t(14;16; n = 10). Four patients (8%) had extramedullary disease.

“Responses deepened over time with an overall response rate before maintenance of 100%, including 81% [of patients who had a] complete response,” reported the team. In the 33 evaluable patients, the premaintenance MRD negativity rate (next-generation sequencing, 10^-6) was 94%. Further, after a median follow up of 32 months, the 24-month progression-free survival [rate] was 87%, and the 24-month overall survival [rate] was 94%.

Dr. Touzeau and co-investigators also noted that 21 patients (42%) ultimately discontinued their participation in the study because of stem cell collection failure, disease progression, adverse events, or consent withdrawal. Overall, seven patients died, five of disease progression and two of infection.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.

2023 ASH Annual Meeting & Exposition

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