In an analysis from the phase III MAIA trial reported in the Journal of Clinical Oncology, Perrot et al found that the combination of daratumumab, lenalidomide, and dexamethasone (D-Rd) was associated with better health-related quality-of-life outcomes vs lenalidomide and dexamethasone (Rd) in transplant-ineligible patients with newly diagnosed multiple myeloma.
“D-Rd compared with Rd was associated with faster and sustained clinically meaningful improvements in patient-reported outcomes, including pain, in transplant-ineligible patients with newly diagnosed multiple myeloma regardless of age, baseline ECOG status, or depth of treatment response.”— Perrot et al
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Study Details
In the trial, 737 transplant-ineligible patients with newly diagnosed disease were randomly assigned to receive D-Rd (n = 368) or Rd (n = 369) in 28-day cycles. Patient-reported outcomes were assessed using the EORTC Quality of Life Questionnaire Core 30-item (QLQ-C30) and the EuroQol 5-dimensional visual analog scale at baseline and every 3 months during treatment.
Key Findings
Compliance with patient-reported outcome assessments was > 90% at baseline and remained at > 78% through cycle 12 (12 months) in both groups.
QLQ-C30 global health status scores improved from baseline in both groups and were consistently greater with D-Rd vs Rd. Least squares mean changes from baseline were 4.5 vs 1.5 at cycle 3, 6.4 vs 5.6 at cycle 6, 8.2 vs 7.0 at cycle 9, and 8.4 vs 5.4 at cycle 12, with the difference at cycle 3 being statistically significant (P = .0454). The global health status benefit in the D-Rd group was observed regardless of age, Eastern Cooperative Oncology Group (ECOG) performance status, or depth of response.
Least squares mean reductions from baseline in QLQ-C30 pain scores were −17.9 vs −11.0 at cycle 3, −18 vs −14.1 at cycle 6, −20.1 vs −16.9 at cycle 9, and −17.3 vs −14.9 at cycle 12, with the reduction at cycle 3 being statistically significant (P = .0007). Reductions in pain scores with D-Rd were clinically meaningful regardless of age, ECOG status, or depth of response.
Greater proportions of D-Rd vs Rd patients reported meaningful improvement at any time in QLQ-C30 fatigue (62.2% vs 52%) and physical functioning (49.7% vs 40.9%). For all patient-reported outcomes, patients in the D-Rd group were significantly more likely to experience improvement.
Patient-reported outcome improvements were observed with both D-Rd and Rd on the EuroQol 5-dimensional visual analog scale. Least squares mean changes from baseline scores were 4.9 vs 2.5 at cycle 3, 8.0 vs 5.7 at cycle 6, 10.2 vs 7.7 at cycle 9, and 10.1 vs 4.9 at cycle 12, with the differences at cycle 3 and cycle 12 being statistically significant (P = .002).
The investigators concluded, “D-Rd compared with Rd was associated with faster and sustained clinically meaningful improvements in patient-reported outcomes, including pain, in transplant-ineligible patients with newly diagnosed multiple myeloma regardless of age, baseline ECOG status, or depth of treatment response.”
Aurore Perrot, MD, PhD, of Institut Universitaire du Cancer Toulouse-Oncopole, France, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Janssen Research & Development, LLC, and Janssen Global Services, LLC. For full disclosures of the study authors, visit ascopubs.org.
