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On Sunday 16 June at the 24th Congress of the European Hematology Association (EHA), Henrik Gregersen from Aalborg University Hospital, Aalborg, DK, presented the results of the CARFI phase II trial on behalf of the Nordic Myeloma Study Group (NMSG).1
The current standard of care following autologous stem cell transplant (ASCT) for patients with relapsed or refractory multiple myeloma (RRMM) is lenalidomide maintenance. Preliminary results from a small phase I/II trial revealed that carfilzomib maintenance led to a 12-month progression-free survival (PFS) rate of 66.7% and a 12-month overall survival (OS) of 88.1%, indicating the potential benefit of carfilzomib in this setting.2
The open-label, randomized study (NCT025724921) investigated the efficacy and safety of carfilzomib as part of induction and maintenance therapy (with dexamethasone) for salvage ASCT, in patients with RRMM. There were dual primary endpoints of the trial. Firstly, the comparison of the time-to-progression (TTP) after salvage ASCT plus carfilzomib-based induction versus TTP after high-dose melphalan with ASCT. Secondly, comparison of TTP between RRMM patients receiving carfilzomib plus dexamethasone versus observation after salvage ASCT.
MM, multiple myeloma |
|
Baseline characteristic |
Total cohort (N=200) |
---|---|
Median age (range) |
62 (56–66) |
Time from MM diagnosis (range) |
41.3 (30.0–58.4) |
Bone disease |
83% |
Performance status I–II |
91.5% |
High-risk cytogenetics |
19.5% |
The results of the phase II CARFI trial indicate that maintenance therapy with Car+Dex following salvage ASCT, prolongs TTP for patients with RRMM but also is associated with a higher infection risk. No difference was observed in TTP between patients who received salvage ASCT with Car+Cy+Dex induction versus the ones receiving high-dose melphalan with ASCT.
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