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IKEMA

Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial

Phase 3N = 302NCT03275285

Population
Relapsed or refractory multiple myeloma after one to three previous lines, with measurable serum or urine M-protein.
Design
Open-label randomised phase 3 trial at 69 centres in 16 countries: 302 patients were randomly assigned 3:2 to isatuximab plus carfilzomib-dexamethasone or carfilzomib-dexamethasone. The primary end point was progression-free survival in the intention-to-treat population.
Primary endpoint
PFS
Arms
  • Isatuximab + Kd (experimental, n = 179): Isatuximab 10 mg/kg with carfilzomib and dexamethasone
  • Kd (control, n = 123): Carfilzomib and dexamethasone
People
Moreau P
PFSHR 0.53
Show the numbers
Results reported for IKEMA
EndpointAnalysisIsatuximab + KdKdEffect
PFSITT population (302)primaryMoreau 2021—median 19.15 monthsHR 0.53P=0.0007 (one-sided)The hazard ratio is reported with a 99% confidence interval of 0.32 to 0.89. Median progression-free survival was not reached in the isatuximab group; the control median has a 95% CI of 15.77 months to not reached. Grade 3 or worse treatment-emergent adverse events occurred in 77% versus 67%; fatal treatment-emergent adverse events in six patients (3%) versus four (3%).
Results reported for IKEMA
EndpointAnalysisIsatuximab + KdKdEffect
PFSITT population (302)primaryMoreau 2021—median 19.15 monthsHR 0.53P=0.0007 (one-sided)The hazard ratio is reported with a 99% confidence interval of 0.32 to 0.89. Median progression-free survival was not reached in the isatuximab group; the control median has a 95% CI of 15.77 months to not reached. Grade 3 or worse treatment-emergent adverse events occurred in 77% versus 67%; fatal treatment-emergent adverse events in six patients (3%) versus four (3%).
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%010203040Months (modelled)
  • Kd (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsKd
0100.0%
1264.8%
2441.9%
3627.2%
4817.6%
Primary publication: Moreau P, Dimopoulos MA, Mikhael J, Yong K, Capra M, Facon T, et al. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021;397(10292):2361-2371. PubMedDOI

Appears in

Sources

  1. Moreau P, Dimopoulos MA, Mikhael J, Yong K, Capra M, Facon T, et al. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021;397(10292):2361-2371.

    PubMedDOI