Ide-cel Improves HRQOL Vs Standard Treatment in R/R Multiple Myeloma

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Patient-reported outcomes support the clinical benefits of ide-cel among patients with relapsed/refractory multiple myeloma.

"These findings further support the superior clinical benefits of ide-cel observed in the KarMMa-3 trial, suggesting that a one-time infusion with ide-cel offers longer disease control with improved HRQOL compared with standard regimens given to patients who are [triple-class exposed] with relapsed and refractory multiple myeloma," according to the study authors.

"These findings further support the superior clinical benefits of ide-cel observed in the KarMMa-3 trial, suggesting that a one-time infusion with ide-cel offers longer disease control with improved HRQOL compared with standard regimens given to patients who are [triple-class exposed] with relapsed and refractory multiple myeloma," according to the study authors.

Treatment with idecabtagene vicleucel (ide-cel; Abecma) improved health-related quality of life (HRQOL) among patients with triple-class exposed relapsed/refractory multiple myeloma compared with standard-of-care therapy, according to patient-reported outcomes (PROs) from the phase 3 KarMMaa-3 trial (NCT03651128).

Ide-cel produced consistent PROs of interest apart from QLQ-MY 20 disease symptoms, adverse effects (AEs) of treatment, and EQ-5D-5L index scores, in which some improvements did not surpass within-group minimally important difference thresholds. Those who received standard therapy had deterioration in EORTC QLQ-C30 cognitive functioning scores that exceeded the within-group minimally important difference threshold.

At an individual patient level, primary PROs of interest demonstrated meaningful improvements with ide-cel vs standard therapy with most follow-up visits, which were especially pronounced in the EORTC QLQ-C30 GHS-QoL, physical functioning, and fatigue domains. The overall least-squares mean changes in the primary domains of interest were significant (nominal P <.05), as effect sizes ranged from 0.3 to 0.7 and indicated an improvement in 7 of 9 primary domains of interest with ide-cel. These domains included the EORTC QLQ-C30 GHS-QoL, physical functioning, cognitive functioning, fatigue, and pain domains; QLQ-MY20 AEs of treatment domain; and the EQ-5D-VAS.

Investigators highlighted significant differences in secondary domains of interest including the EORTC QLQ-C30 domains of emotional functioning, social functioning, dyspnea, insomnia, and constipation, as well as the QLQ-MY20 domains of future perspective and body image. All differences in these domains surpassed the between-group minimally important difference for improvement apart from the QLQ-MY20 domains of body image and future perspective.

“As a complementary analysis to the progression-free survival benefits observed with ide-cel for patients who are [triple-class exposed] with relapsed and refractory multiple myeloma, this study showed meaningful and longer-lasting improvements with ide-cel across several PRO domains compared with standard regimens,” Michel Delforge, MD, a professor in the Department of Hematology at University Hospital Leuven in Leuven, Belgium, and co-authors wrote. “These findings further support the superior clinical benefits of ide-cel observed in the KarMMa-3 trial, suggesting that a one-time infusion with ide-cel offers longer disease control with improved HRQOL compared with standard regimens given to patients who are [triple-class exposed] with relapsed and refractory multiple myeloma.”

Patients in the KarMMa-3 trial were randomly assigned 2:1 to receive ide-cel (n = 254) or standard therapy (n = 132) between May 2019 and April 2022. Options in the standard therapy arm included daratumumab (Darzalex) plus pomalidomide (Pomalyst) and dexamethasone; daratumumab plus bortezomib (Velcade) and dexamethasone; ixazomib (Ninlaro) plus lenalidomide and dexamethasone; carfilzomib (Kyprolis) plus dexamethasone; and elotuzumab (Empliciti) plus pomalidomide and dexamethasone.

In this HRQOL analysis, investigators assessed all domains of the EORTC QLQ-C30, EORTC QLQ-MY20, and EQ-5D-5L while selecting 9 domains as the most clinically relevant to the study population. These domains included the EORTC QLQ-C30 GHS-QoL, physical functioning, cognitive functioning, fatigue, and pain scores; the QLQ-MY20 disease symptoms and AEs of treatment scores; and EQ-5D-5L index score and EQ-5D-VAS.

Patients 18 years and older with relapsed/refractory multiple myeloma who received prior treatment with 2 to 4 lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and daratumumab were eligible for enrollment on the trial. Having disease progression within 60 days following the last prior line of therapy was another requirement for enrollment.

The median patient age was 63 years (IQR, 55-68) in the intent-to-treat (ITT) population. Additionally, most patients were White (65%) followed by Black or African American (9%), Hispanic or Latino (5%), and Asian (3%). Investigators reported that baseline characteristics were generally comparable between the treatment arms, although more patients in the standard regimen group were Black or African American (14%) compared with those who received ide-cel (7%).

The hazard ratio for time to confirmed improvement was significantly shorter with ide-cel vs standard treatment for all EORTC QLQ-C30 domains except role functioning, diarrhea, and financial difficulties (P <.05). Additionally, the hazard ratio for time to confirmed deterioration was significantly longer in the ide-cel arm for the QLQ-C30 domains of emotional functioning, cognitive functioning, dyspnea, insomnia, and constipation, as well as the QLQ-MY20 AEs of treatment domain (P <.05).

Reference

Delforge M, Patel K, Eliason L, et al. Health-related quality of life in patients with triple-class exposed relapsed and refractory multiple myeloma treated with idecabtagene vicleucel or standard regimens: patient-reported outcomes from the phase 3, randomised, open-label KarMMa-3 clinical trial. Lancet Haematol. 2024;11:e216-227. doi:10.1016/S2352-3026(24)00005-X

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