The addition of ixazomib to cyclophosphamide and dexamethasone (ICD) did not improve outcomes in patients with relapsed multiple myeloma (MM) after prior treatment with thalidomide, lenalidomide, and a proteasome inhibitor, according to results of the MUKeight trial.
The trial included 112 patients randomized to receive ICD (n=58) or cyclophosphamide and dexamethasone alone (CD; n=54). The patients had a median age of 70 years and received a median of four prior lines of therapy. The majority (74%) were classified as frail.
The median progression-free survival was 5.6 months in the ICD arm compared with 6.7 months in the CD arm (hazard ratio=1.21; 80% CI, 0.9-1.6; P=.3634).
“A likely explanation for why ICD was not superior to CD may be that the combination was too toxic for the patient population included,” the researchers wrote.
Response rates were also similar between the two arms. The response rate was 42.1% in the ICD arm and 39.6% in the CD arm. Median overall survival was 14.1 months for ICD compared with 19.1 months for CD.
Additionally, dose modifications or omissions, and serious adverse events occurred more often in patients assigned to the ICD arm.
The researchers noted the results could have been affected by the high proportion of patients on study that were considered frail, but also acknowledged that this proportion of frail patients is “naturally closer to the real-world situation outside of clinical trials.”
However, they also noted that “at least in the frail and advanced patient population enrolled, the inexpensive and all-oral combination of CD can indeed be associated with satisfactory responses, a finding that is particularly relevant for MM patients who do not have access to costly novel drug combinations.”
Auner HW, Brown SE, Walker K, et al. Ixazomib with cyclophosphamide and dexamethasone in relapsed or refractory myeloma: MUKeight phase II randomized controlled trial results. Blood Cancer J. 2022;12(4):52.
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