Shah, N. (Nina)
- Publications
- item.page.relationships.isContributorAdvisorOfPublication
- item.page.relationships.isContributorOfPublication
2 results
Search Results
Now showing 1 - 2 of 2
- Analysis of patient-reported experiences up to 2 years after receiving idecabtagene vicleucel (ide-cel, bb2121) for relapsed or refractory multiple myeloma: Longitudinal findings from the phase 2 KarMMa trial(2023) Delforge, M. (M.); Dhanda, D.S. (Devender S.); Shah, N. (Nina); Miera, M. (Matthew); Devlen, J. (Jennifer); Moshkovich, O. (Olga); Rodriguez-Otero, P. (Paula); Campbell, T.B. (Timothy B.); Munshi, N.C. (Nikhil C.); Gerould, H. (Heather); Braverman, J. (Julia); Lanar, S. (Sally)Objective: To understand the long-term experience of patients receiving ide-cel chimeric antigen receptor T (CAR T) cell therapy for relapsed or refractory multiple myeloma in the pivotal phase 2 KarMMa trial.Methods: This qualitative study analyzed semi-structured patient interviews 6-24 months after ide-cel infusion. Thematic analysis with quantitative and longitudinal analyses explored patient perceptions of ide-cel treatment experience, advantages and disadvantages, and long-term health-related quality of life impact. Patient journeys were developed from narrative analysis of perceived treatment benefits with known remission length.Results: Interviews with 45 patients 6-24 months postinfusion were analyzed; all reported >= 1 ide-cel treatment advantage, most often related to efficacy (n = 42/45, 93%), few or no side effects (n = 35/45, 78%), and avoidance of other treatments (n = 34/45, 76%). Patients generally reported 6-month improvements in physical health, functioning, emotional well-being, social life, and outlook on the future; these improvements mostly remained stable through 18 and 24 months. The most common patient journeys comprised physical, func-tioning, or emotional benefit with remission < 2 years.Conclusions: Longitudinal analysis of patient experiences showed sustained benefits and preference for ide-cel up to 24 months after treatment.Trial Registration Number and Date: NCT03361748. December 5, 2017.
- KarMMa-RW: comparison of idecabtagene vicleucel with realworld outcomes in relapsed and refractory multiple myeloma(Springer Nature, 2021) Jagannath, S. (Sundar); Lin, H.Y. (H.Y.); Goldschmidt, H. (Hartmut); Reece, D. (Donna); Nooka, A. (Ajay); Senin, M.A. (María Alicia); Rodriguez-Otero, P. (Paula); Powles, R. (Ray); Matsue, K. (Kosei); Shah, N. (Nina); Anderson Jr, L.D. (Larry D.); Streetly, M. (Matthew); Wilson, K. (Kimberly); Le, H.V. (Hoa Van); Swern, A.S. (Arlene S.); Agarwal, A. (Amit); Siegel, D.S. (David S.)Patients with relapsed and refractory multiple myeloma (RRMM) who are triple-class exposed (to an immunomodulatory agent, proteasome inhibitor, and anti-CD38 antibody) have limited treatment options and there is no standard of care. Idecabtagene vicleucel (ide-cel, bb2121), a BCMA-directed CAR T-cell therapy, demonstrated efficacy in triple-class exposed RRMM patients in the KarMMa trial (NCT03361748). In this retrospective study (KarMMa-RW), patient-level data from triple-class exposed RRMM patients were merged into a single data model and compared with KarMMa using trimmed stabilized inverse probability of treatment weighting. Endpoints included overall response rate (ORR; primary), rate of very good partial response or better (≥VGPR), progression-free survival (PFS), and overall survival (OS). Of 1949 real-world triple-class exposed RRMM patients, 190 received subsequent (index) line of therapy and met KarMMa eligibility criteria (Eligible RRMM cohort). With a median follow-up of 13.3 months in KarMMa and 10.2 months in Eligible RRMM, ORR, and ≥VGPR were significantly improved in KarMMa versus Eligible RRMM (ORR, 76.4% vs 32.2%; ≥VGPR, 57.9% vs 13.7%; both P < 0.0001) as were PFS (11.6 vs 3.5 months; P = 0.0004) and OS (20.2 vs 14.7 months; P = 0.0006). This study demonstrated that ide-cel significantly improved responses and survival compared with currently available therapies in triple-class exposed RRMM.