Skip to content
Bending the Curve Trial by Trial
?

KarMMa

Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma (KarMMa)

Phase 2N = 140NCT03361748

Population
Relapsed and refractory myeloma after at least three previous regimens including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
Design
Phase 2 single-arm study of ide-cel (target doses 150 to 450 x 10^6 CAR-positive T cells). The primary end point was overall response (partial response or better); a key secondary end point was complete response or better. 140 patients were enrolled and 128 received ide-cel.
Primary endpoint
ORR
Arms
  • Idecabtagene vicleucel (experimental, n = 128): Ide-cel, target doses 150 to 450 x 10^6 CAR+ T cells
People
Munshi NC
Show the numbers
Results reported for KarMMa
EndpointAnalysisIdecabtagene vicleucelControlEffect
ORRTreated patients (128)primarymedian follow-up 13.3 monthsMunshi 202173%—Cytokine release syndrome occurred in 84% (grade 3 or higher in 5%); neurotoxic effects in 18% (grade 3 in 3%); neutropenia in 91%, anemia 70% and thrombocytopenia 63% across all grades.
≥CR rateTreated patients (128)primaryMunshi 202133%——
MRDTreated patients (128)primaryMunshi 202126%—This was 79% of the 42 patients who had a complete response or better.
PFSTreated patients (128)primaryMunshi 2021median 8.8 months (5.6–11.6)——
Results reported for KarMMa
EndpointAnalysisIdecabtagene vicleucelControlEffect
ORRTreated patients (128)primarymedian follow-up 13.3 monthsMunshi 202173%—Cytokine release syndrome occurred in 84% (grade 3 or higher in 5%); neurotoxic effects in 18% (grade 3 in 3%); neutropenia in 91%, anemia 70% and thrombocytopenia 63% across all grades.
≥CR rateTreated patients (128)primaryMunshi 202133%——
MRDTreated patients (128)primaryMunshi 202126%—This was 79% of the 42 patients who had a complete response or better.
PFSTreated patients (128)primaryMunshi 2021median 8.8 months (5.6–11.6)——
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Idecabtagene vicleucel (experimental)

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

Data table (modelled values)
MonthsIdecabtagene vicleucel
0100.0%
662.3%
1142.0%
1726.2%
2217.7%
Primary publication: Munshi NC, Anderson LD Jr, Shah N, Madduri D, Berdeja J, Lonial S, et al. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021;384(8):705-716. PubMedDOI

Appears in

Sources

  1. Munshi NC, Anderson LD Jr, Shah N, Madduri D, Berdeja J, Lonial S, et al. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021;384(8):705-716.

    PubMedDOI