ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
This website is best viewed using the horizontal display on your tablet device.
This website is best viewed using the vertical display on your mobile device.
Mean decrease of 12.5 points from baseline (mean: 40.7 points) to month 18 (mean: 25.0 points)†
Mean decrease of 16.7 points from baseline (mean: 41.5 points) to month 18 (mean: 27.1 points)†
Mean increase of 19.2 points from baseline (mean: 67.0 points) to month 18 (mean: 78.3 points)†
Remained stable from baseline (mean: 81.5 points) to month 18 (mean: 85.4 points)†
Mean increase of 7.3 points from baseline (mean: 59.1 points) to month 18 (mean: 77.1 points)†
EORTC QLQ-C30 domains primarily assessed HRQoL metrics associated with the disease itself, rather than the treatment.
QoL was a secondary endpoint of KarMMa and was not statistically tested in the setting of a single-arm trial. QoL data are not in the USPI and should be interpreted with caution in a single-arm trial. The statistical significance of QoL is not known.1
Analysis limitations: This analysis is exploratory in nature and definitive conclusions should not be drawn. mTTNT is not in the USPI and should be interpreted with caution in a single-arm trial.
(95% CI, 12.1-20.5) (N=100)
QoL assessments occurred at screening, prior to lymphodepletion, day of infusion, monthly up to 6 months post infusion, and every 3 months up to 24 months post infusion. Results were self-reported using EORTC QLQ-C30 subscales.1,2 Questionnaire completion rates ranged from 98% at baseline to 70%-90% between month 1 and month 6, and 40%-70% until month 18, with 88 patients reporting at month 1, 78 patients at month 2, 45 patients at month 12, and 8 patients at month 18.2 Only within-group effects are reported because there was no control arm in the trial. For the assessment of Global Health Status score, patients were asked to rate their overall health and overall QoL; for Physical Functioning score, patients were asked to rate impact on walking, eating, washing yourself, and other physical activities; and for Cognitive Functioning score, patients were asked to rate impact on difficulty in concentrating and remembering things.5
Based on a 100-point scale.
As of the data cutoff date, 56 (56%) patients received subsequent MM therapy (including ABECMA retreatment). 44 (44%) patients were not evaluable or had missing data. No imputation of missing data was performed; missing data may be a source of bias.
EORTC QLQ-C30=European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30; HRQoL=health-related quality of life; MM=multiple myeloma; mTTNT=median time to next treatment; QoL=quality of life.