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Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Posted: Friday, January 6, 2023
The ASCENT study, conducted by Shaji K. Kumar, MD, of the Mayo Clinic, Rochester, Minnesota, and colleagues, was designed to determine whether intense therapy applied at the precursor phase might potentially eradicate the malignant clone in smoldering multiple myeloma and lead to improved clinical outcomes. The results of this study, which indicated this quadruplet therapy combination was well tolerated, were presented during the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 757).
“The combination of daratumumab, carfilzomib, lenalidomide, and dexamethasone given for a fixed duration of 2 years was associated with high response rates and deep responses including high rates of [measurable] residual disease [MRD] negativity,” concluded the investigators. “With nearly half of the patients still receiving therapy, the depth of response is expected to improve.”
In total, 87 patients with high-risk smoldering multiple myeloma were enrolled. Participants received treatment in three phases: induction (cycles 1–6); consolidation (cycles 7–12); and maintenance (cycles 13–24). Individuals received carfilzomib and lenalidomide for the first 12 cycles, daratumumab for the first 2 cycles then cycles 3 through 6, and dexamethasone for the first 12 cycles.
At the median follow-up of 25.8 months, 41 patients completed all 24 cycles, and 38 remained on treatment; 10 patients went off study treatment because of withdrawal by subject, physician decision, adverse events, disease progression, or death. The best overall response rate was 97%, with a 37% rate of stringent complete response, a 26% rate of complete response, a 29% rate of very good partial response, a 2% rate of partial response, and a 1% rate of stable disease.
Most patients (84%) achieved MRD negativity in the bone marrow, with a median time to MRD negativity of 6.6 months. Although the median progression-free survival was not reached, the rate at 3 years was 89.9%; three patients experienced disease progression. Nearly all patients (97%) experienced toxicity of any grade, with 13 and 44 participants experiencing hematologic and nonhematologic toxicities, respectively.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.
2022 ASH Annual Meeting and Exposition
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