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Treatment options for patients with multiple myeloma (MM) after autologous hematopoietic stem cell transplantation (ASCT) have been an area of active exploration by researchers
This international open-label phase 3 randomized trial enrolled newly diagnosed MM patients who received ≤12 months of induction therapy followed by a single ASCT and achieved at least stable disease after 100 days
Patients randomized to the KRd arm received KRd treatment in a 28-day cycle
The primary endpoint of the study was progression-free survival (PFS)
figure 1
02Research result
As of October 21, 2020, 180 patients (n=87 in R arm; n=93 in KRd arm) were enrolled, and 2 patients withdrew from the study before starting treatment; data cutoff date is December 31, 2021
figure 2
At a median follow-up of 33.
image 3
After 6 cycles, 44% and 27% of patients in the KRd group (n=90) and R group (n=84), respectively, achieved MRD negativity (p=0.
Figure 4
At data cutoff, 20 patients had died [KRd vs R: 9 (9.
8%) vs 11 (12.
8%)]
.
The median OS was NR (95% CI NR-NR) and 81.
8 months (95% CI 61.
8-NR) in the KRD and R groups, respectively (HR 0.
92, p=0.
86)
.
Ninety percent of patients in the KRd group and 87% in the R group survived
.
All grades of toxicity were roughly equivalent between the two groups
.
The most common grade 3+ adverse events (AEs) and AEs of particular concern were neutropenia (KRd vs R: 47% vs 63%), thrombocytopenia (13% vs 7%), infection ( 17% vs 8%), cardiovascular toxicity (4% vs 6%), and secondary malignancies (0 vs 1 patient)
.
Analysis conclusion
This is the first randomized phase III trial to demonstrate that prolonged KRd therapy after transplantation is superior to R maintenance therapy in PFS
.
Therefore, prolonged KRd therapy after MRD/risk-adapted ASCT may become a new alternative and standard of care
.
Reference source:
Andrzej Jakubowiak, et al.
Atlas: a phase 3 randomized trial of carfilzomib, lenalidomide, and dexamethasone versus lenalidomide alone after stem-cell transplant for multiple myeloma.
2022IMS.
Abstract#OAB-010.
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