Single HDM/ASCT Non-inferior to Tandem HDM/ASCT in Newly Diagnosed Multiple Myeloma
Single high-dose melphalan/autologous transplantation was non-inferior to tandem HDM/ASCT in patients with multiple myeloma.
Single high-dose melphalan/autologous transplantation (HDM/ASCT) was non-inferior to tandem HDM/ASCT in patients with multiple myeloma, according to a study published in the British Journal of Haematology.1
Investigators sought to determine whether single (arm A) versus tandem (arm B ) HDM/ASCT was non-inferior in terms of 2-year event-free survival (EFS) in patients with newly diagnosed multiple myeloma in this prospective, randomized phase 3 trial.
A total of 358 evaluable patients were included in the intention-to-treat population; 177 patients were in arm A and 181 were in arm B.
Results showed that after a median follow-up of more than 11 years, non-inferiority was demonstrated using the planned non-inferior threshold of 15% of the 2-year EFS rate. No differences were found in the EFS or overall survival rates (P = .53; P = .33, respectively).
This was consistent with the results of a per-protocol analysis, which included patients who received the intervention (single/tandem HDM/ASCT; 156 patients/93 patients) and those who did not receive a second HDM/ASCT due to medical reasons (12%). A total of 26% of patients in the tandem arm refused a second HDM/ASCT due to non-medical reasons.
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The rates of complete responses increased from first to second HDM/ASCT in both the intention-to-treat and per-protocol set of the tandem arm (both P = .04). Ten-year overall survival for the entire intention-to-treat population was 34% (95% CI, 29 – 40). Overall survival after first relapse was significantly shortened in the tandem arm (P = .04).
- Mai EK, Benner A, Bertsch U, et al.