Multiple myeloma (MM) is a complex disease often associated with substantial morbidity and mortality that can carry significant burden on patients both physically and mentally. Daratumumab (D) and combination treatments for patients who are transplant-ineligible and newly diagnosed with MM (TIE NDMM) and relapsed/refractory MM (RRMM) have demonstrated positive results in this population. However, the complexity of this cancer can significantly affect the health-related quality of life (HRQoL) in these patients, and these HRQoL issues should be taken into account when assessing treatment patterns.
At the 2022 annual ISPOR (International Society for Pharmacoeconomics and Outcomes Research) meeting, Charu and colleagues presented a poster highlighting results from a targeted literature review of HRQoL in patients with TIE NDMM and RRMM receiving D combination regimens. The review assessed existing data generated via searches of PubMed, Cochrane, and CT.gov databases. Randomized controlled trials between 2011 and 2021 studying treatment regimens containing D in combination with lenalidomide-dexamethasone (Rd) or bortezomib-dexamethasone (Vd), or bortezomib-melphalan-dexamethasone (VMP) were reviewed.
A total of 251 records were identified in the literature search. Of those, 4 open-label phase 3 trials using D combination regimens in patients with TIE NDMM and RRMM were selected for analysis: CASTOR, POLLUX, ALCYONE, and MAIA. In all 4 trials, HRQoL was measured using EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire) and the EQ-5D-5L (EuroQol 5 dimensions) instruments.
The ALCYONE (D-VMP vs VMP) and MAIA (D-Rd vs Rd) trials enrolled a total of 1443 patients with TIE NDMM. Both trials showed evidence of HRQoL benefits with D combination compared with the respective comparator arms. In addition, patients maintained clinically meaningful improvements in global health status (GHS) and function and symptoms scales. The CASTOR (D-Vd vs Vd) and POLLUX (D-Rd vs Rd) trials evaluated a total of 1068 patients with RRMM. In the POLLUX trial, researchers noted “the mean changes from baseline were significantly greater in the D-Rd group, however the magnitude of [patient-reported outcome (PRO)] change suggested no meaningful clinical impact on HRQoL.” In the CASTOR trial, no significant differences were seen between the D-Vd and Vd groups for the first 8 cycles of therapy. Subsequently, PROs for the D-Vd group demonstrated improvements in GHS, pain, and visual analog scales from baseline.
Results of this literature review suggest that patients with both TIE NDMM and RRMM receiving D combination therapies show improvement in HRQoL. Given the inherent methodologic limitations of the literature review, more rigorous studies are needed to assess the degree to which combination regimens affect patient HRQoL.
Source
- Charu R, Manupati R, Singh JA, et al. 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 review. Poster presented at: ISPOR; May 15-18 2022; Washington, DC. Accessed May 31, 2022.