Iberdomide plus daratumumab and dexamethasone versus daratumumab, bortezomib, and dexamethasone in patients with relapsed or refractory multiple myeloma (EXCALIBER-RRMM): an open-label, randomised, controlled, phase 3 trial.
Sagar Lonial, Meletios A Dimopoulos, Maria Gavriatopoulou et al.
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In 30 seconds
EXCALIBER-RRMM is an ongoing, open-label, randomised phase 3 trial comparing iberdomide, daratumumab, and dexamethasone with daratumumab, bortezomib, and dexamethasone in adults with relapsed or refractory multiple myeloma after one to two previous treatment lines. In the primary analysis of the first 420 patients, after a median follow-up of 15·7 months, MRD-negative complete response occurred in 41% versus 21%, respectively (stratified proportion difference 20·1% [95% CI 11·5-28·6, p<0·0001]). Progression-free survival assessment remains ongoing.
Key findings
- MRD-negative complete response was achieved by 85 (41%) of 207 patients receiving iberdomide-based therapy and 44 (21%) of 213 receiving the comparator regimen.
- The stratified proportion difference was 20·1% [95% CI 11·5-28·6, p<0·0001]; the odds ratio was 2·8 [95% CI 1·8-4·3].
- Grade 3 or grade 4 adverse events occurred in 187 (92%) of 204 patients in the iberdomide group; the abstract excerpt does not provide the comparator rate.
Why it matters
The trial reports a higher rate of deep response with the iberdomide combination than with a daratumumab- and bortezomib-based regimen in this relapsed or refractory population. The result may inform evaluation of treatment options, but MRD-negative complete response is the reported primary analysis; the trial’s progression-free survival endpoint is still being assessed.
What to keep in mind
This summary reports the primary analysis in the first 420 patients, with median follow-up of 15·7 months. Progression-free survival assessment is ongoing, so comparative survival benefit is not established here.