KEY TAKEAWAYS
- The IFM 2018-04 phase II trial aimed to evaluate the feasibility of an intensive strategy with Dara-KRd induction, consolidation, and double transplant in HR TE NDMM.
- The primary endpoint was to determine the feasibility.
- The study found that Dara-KRd induction/consolidation with tandem transplant proved feasible and effective in high-risk cytogenetic TE NDMM pts, achieving high MRD negativity rates and PFS.
High-risk cytogenetics in transplant-eligible newly diagnosed multiple myeloma (NDMM) is associated with poor outcomes. Researchers aimed to evaluate the feasibility of an intensive strategy with Dara-KRd induction, consolidation, and double transplant in HR TE NDMM.
The study involved 50 previously untreated patients(pts) with high-risk cytogenetics, including 17p deletion (40%), t(4;14) (52%), or t(14;16) (20%). The primary endpoint was achieved with 72% of pts completing the second transplant. About 40% of pts discontinued the study, mainly due to stem-cell collection failure (16%), disease progression (14%), adverse events(AEs) (8%), and consent withdrawal (2%).
Grade 3-4 AEs during Dara-KRd induction/consolidation (>5% of pts) included neutropenia (39%), anemia (12%), thrombocytopenia (7%), and infection (6%). About 4 pts discontinued treatment due to severe AEs, including COVID-19 infection, drug-induced hepatitis, JC virus-related encephalopathy, and intracerebral hemorrhage. About 7 pts died, with 5 due to disease progression and 2 due to infection.
The overall response rate(ORR) was 100% among pts completing the second transplant, with 81% achieving a complete response. In evaluable pts (33/36), the pre-maintenance Minimal Residual Disease negativity rate (NGS, 10-6) was 94%. After a median follow-up of 32 months, the 24-month progression-free survival(PFS) rate was 87% (78-87%), and the 24-month overall survival(OS) rate was 94% (87-100%).
The study found that Dara-KRd induction/consolidation with tandem transplant proved feasible and effective in high-risk cytogenetic TE NDMM pts, achieving high MRD negativity rates and PFS.
Source: https://imsannual2023.eventscribe.net/fsPopup.asp?PresentationID=1306639&mode=presInfo
Clinical Trial: https://clinicaltrials.gov/study/NCT03606577
Touzeau C. Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone with tandem transplant in high-risk newly diagnosed myeloma patients: final results of the phase 2 study IFM 2018-04. Presented at: 20th International Myeloma Society Annual Meeting and Exposition.2023
