KarMMa-3
Trial question
What is the role of idecabtagene vicleucel in patients with relapsed and refractory multiple myeloma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 386
386 patients (151 female, 235 male).
Inclusion criteria: adult patients with triple-class-exposed relapsed and refractory multiple myeloma who had received 2-4 regimens previously.
Key exclusion criteria: nonsecretory multiple myeloma; inadequate pulmonary function; active history of plasma cell leukemia; known CNS involvement with myeloma.
Interventions
N=254 idecabtagene vicleucel (at a dose of 150×10⁶ to 450×10⁶ CAR-positive T cells).
N=132 standard regimen (either one of the regimens including daratumumab, pomalidomide, and dexamethasone; or daratumumab, bortezomib, and dexamethasone; or ixazomib, lenalidomide, and dexamethasone; or carfilzomib and dexamethasone; or elotuzumab, pomalidomide, and dexamethasone).
Primary outcome
Median progression-free survival
13.3 months
4.4 months
13.3 months
10.0 months
6.7 months
3.3 months
0.0 months
Idecabtagene
vicleucel
Standard
regimen
Significant
increase ▲
Significant increase in median progression-free survival (13.3 months vs. 4.4 months; AD 8.9 months, 95% CI 3.62 to 14.18).
Secondary outcomes
Significant increase in overall response (71% vs. 42%; AD 29%, 95% CI 11.79 to 46.21).
Safety outcomes
No significant difference in any adverse events.
Significant differences in neutropenia (78% vs 44%), anemia (66% vs. 36%), thrombocytopenia (54% vs. 29%).
Conclusion
In adult patients with triple-class-exposed relapsed and refractory multiple myeloma who had received 2-4 regimens previously, idecabtagene vicleucel was superior to standard regimen with respect to median progression-free survival.
Reference
Paula Rodriguez-Otero, Sikander Ailawadhi, Bertrand Arnulf et al. Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2023 Mar 16;388(11):1002-1014.
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