Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial

Abstract

PURPOSE To evaluate the effects of daratumumab, lenalidomide, and dexamethasone (D-Rd) versus lenalidomide and dexamethasone (Rd) on patient-reported outcomes (PROs) in the phase III MAIA study. PATIENTS AND METHODS PROs were assessed on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item and the EuroQol 5-dimensional descriptive system at baseline and every 3 months during treatment. By mixed-effects model, changes from baseline are presented as least squares means with 95% CIs. RESULTS A total of 737 transplant-ineligible (TIE) patients with newly diagnosed multiple myeloma were randomly assigned to D-Rd (n = 368) or Rd (n = 369). Compliance with PRO assessments was high at baseline (> 90%) through month 12 (> 78%) for both groups. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item global health status scores improved from baseline in both groups and were consistently greater with D-Rd at all time points. A global health status benefit was achieved with D-Rd, regardless of age (< 75 and ≥ 75 years), baseline Eastern Cooperative Oncology Group (ECOG) performance status score, or depth of response. D-Rd treatment resulted in significantly greater reduction in pain scores as early as cycle 3 ( P = .0007 v Rd); the magnitude of change was sustained through cycle 12. Reductions in pain with D-Rd were clinically meaningful in patients regardless of age, ECOG status, or depth of response. Similarly, PRO improvements were observed with D-Rd and Rd on the EuroQol 5-dimensional descriptive system visual analog scale score. CONCLUSION D-Rd compared with Rd was associated with faster and sustained clinically meaningful improvements in PROs, including pain, in transplant-ineligible patients with newly diagnosed multiple myeloma regardless of age, baseline ECOG status, or depth of treatment response.

The Burden of a Multiple Myeloma Diagnosis on Patients and Caregivers in the First Year: Western European Findings

“…Other research in TNE NDMM patients found that overall HRQoL recovers after 6 to 12 months of therapy management. 30 , 31 …”

“…Other research in TNE NDMM patients found that overall HRQoL recovers after 6 to 12 months of therapy management. 30,31 As reliance of patients on caregivers increased during the first year after diagnosis, caregiver burden also rose with a peak three months after diagnosis. Those caring for TNE NDMM patients reported greater burden and time dedicated to caring compared to TE individuals.…”

“…[n ‡ ] 94 [32] 96 [24] 80 [38] 15 [43] 13 [31] 6 [23] Presenteeism (base: all working > 0 hours in the past week), impairment % [n ‡ ] 80 [5] 50 [1] 30 [7] 49 [40] 49 [28] 30 [22] Work productivity (base: all working > 0 hours in the past week), impairment % [n ‡ ] 92 [5] 56 [1] 33 [7] 54 [40] 52 [28] 35 [22] Activity both indicate a loss of productivity. To quantify this, an impairment score between 0 and 100 is calculated, with higher numbers indicating greater impairment and less productivity.…”

Immunotherapy of Multiple Myeloma: Promise and Challenges

“…This modification significantly enhances CAR T-cell-based immunotherapy by enriching the product's population of memory-like T-cells to enhance T-cell durability and potency. 220 The drug was the subject of two recent reports of an ongoing dose-escalation study (NCT03274219) of 44 the presence of memory-associated T-cell markers and peak expansion and duration of response, providing some tentative support for the mechanistic hypothesis underlying the product's design. 221,222 Johnson and Johnson's contribution to this arena is ciltacabtagene autoleucel (JNJ-68284528; JNJ-4528; LCAR-B38M; cilta-cel), which differs from other BCMA-targeted T-cell therapies by being directed against two BCMA epitopes (VH1 and VH2), a feature which improves affinity for BCMA-expressing cells.…”

Characterize, Optimize, and Harmonize: Caring for Older Adults With Hematologic Malignancies

“…74 In a quality-of-life analysis of patients enrolled in the MAIA study, 49 49.1% of patients treated with lenalidomide/dexamethasone and 57.3% of patients treated with daratumumab/lenalidomide/ dexamethasone experienced worsening of self-reported cognitive functioning at any point while receiving treatment, though the duration, persistence, and functional impact of these changes are not reported. 75 There is much work to be done to examine cognition in older adults with myeloma longitudinally and identify those at greater risk for cognitive decline.…”