Health-Related Quality of Life (HRQOL) of Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TIE NDMM) and Relapsed/Refractory Multiple Myeloma (RRMM) in Phase III Randomized Controlled Trials (RCTS): A Targeted Literatur ...
Charu R, Manupati R, Singh JA, Rai MK, Gautam R, Kalsey MS, Prasanna R
EVERSANA, Mumbai, India
METHODS: We conducted a targeted search using PubMed, Cochrane and CT.gov databases. Regimens containing daratumumab (D) in combination with lenalidomide and dexamethasone (Rd), bortezomib and dexamethasone (Vd) and bortezomib, melphalan and prednisone (VMP) were selected from year 2011 to 2021.
RESULTS: We identified 251 articles and those not pertaining to inclusion criteria were excluded. Four open-label, phase III RCTs reporting daratumumab combination regimens in TIE NDMM and RRMM patients were included. HRQoL was measured using EORTC QLQ-C30 and the EQ-5D-5L instruments in all four trials. For two RCTs with TIE NDMM patients, a total of 1443 patients were enrolled comparing D-Rd (n=368) with Rd (n=369) in MAIA and D-VMP (n=350) with VMP (n=356) in ALCYONE. Both trials showed evidence of HRQoL benefits for daratumumab combination versus respective comparators and maintained meaningful improvements in global health status (GHS), function and symptoms scales. For two RCTs with RRMM patients, a total of 1068 patients were evaluated comparing D-Rd (n=386) with Rd (n=383) in POLLUX trial and D-Vd (n=251) with Vd (n=247) in CASTOR trial. In POLLUX trial, mean changes from baseline were significantly greater in D-Rd group, however the magnitude of PRO change suggested no meaningful clinical impact on HRQoL. In CASTOR trial, no significant between-group differences were observed for the first eight cycles of therapy, after which PROs result for D-Vd group only showed improvements in GHS, pain and VAS scales from baseline. CONCLUSION: Treatment of TIE NDMM and RRMM with daratumumab in combination has shown encouraging results in the improvement of HRQoL, however further research is suggested to strengthen the findings.
Conference/Value in Health Info
Methodological & Statistical Research, Patient-Centered Research, Study Approaches
Literature Review & Synthesis, Patient-reported Outcomes & Quality of Life Outcomes, PRO & Related Methods