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Clinical Trial
. 2025 May;104(5):2765-2776.
doi: 10.1007/s00277-025-06303-3. Epub 2025 May 23.

Health-related quality of life with daratumumab, bortezomib, melphalan, and prednisone versus bortezomib, melphalan, and prednisone alone in transplant-ineligible patients with newly diagnosed multiple myeloma: analysis of the phase 3 OCTANS study

Weijun Fu  1 , Soo-Mee Bang  2 , Honghui Huang  3 , Kihyun Kim  4 , Wei Li  5 , Gang An  6 , Je-Jung Lee  7 , Zhen Cai  8 , Jie Jin  8 , Yafei Wang  9 , Chor Sang Chim  10 , Robin Carson  11 , Rui Liu  12 , Man Zhao  13 , Xi Chen  14 , Canchan Cui  12 , Jian Hou  15 , Jianxiang Wang  16
Affiliations
Clinical Trial

Health-related quality of life with daratumumab, bortezomib, melphalan, and prednisone versus bortezomib, melphalan, and prednisone alone in transplant-ineligible patients with newly diagnosed multiple myeloma: analysis of the phase 3 OCTANS study

Weijun Fu et al. Ann Hematol. 2025 May.

Abstract
in English, French

In the phase 3 OCTANS study, daratumumab plus bortezomib/melphalan/prednisone (D-VMP) significantly improved response rates and progression-free survival versus VMP alone in transplant-ineligible Asian patients with newly diagnosed multiple myeloma (NDMM). Understanding the impact of treatment on patient-reported outcomes (PROs) is of increasing interest. Here, we report on the impact of D-VMP and VMP on PROs in OCTANS. PROs were a secondary endpoint and were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and the EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaire, administered at screening, every 3 months (Year 1), every 6 months thereafter (until disease progression), and 8 and 16 weeks post disease progression. Treatment effects were estimated using a mixed-effects model with repeated measures. Overall, 220 patients were randomized (D-VMP, n = 146; VMP, n = 74). Compliance rates were 100% at baseline in both treatment groups and remained relatively high by Month 12 (D-VMP, 82.6%; VMP, 67.4%). Comparable improvements from baseline were generally observed between treatment groups across most PRO scores. Significant improvements were observed with D-VMP versus VMP in Global Health Status (GHS) score at 9 months (p = 0.0443) and in social functioning and nausea and vomiting symptom scores at 12 months (p = 0.0042 and p = 0.0012, respectively). In summary, transplant-ineligible Asian patients with NDMM demonstrated improvements in PROs following treatment with D-VMP and VMP; however, greater improvements were observed in GHS, social functioning, and nausea and vomiting symptoms with D-VMP.

ClinicalTrials.gov Identifier: NCT03217812; submitted July 13, 2017.

Trial registration: ClinicalTrials.gov NCT03217812.

Keywords: Daratumumab; Multiple myeloma; Patient-reported outcomes; Transplant-ineligible.

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Conflict of interest statement

Declarations. Ethical approval: The study was conducted in accordance with the ethical principles outlined in the Declaration of Helsinki, Good Clinical Practices, and abided by all applicable regulatory requirements. The study protocol and amendments were reviewed and approved by Independent Ethics Committees and Institutional Review Boards at each participating site, and all patients provided written informed consent. Competing interests: R.C., R.L., X.C., and C.C. are employees of Johnson & Johnson and own stock or stock options. M.Z. is an employee of IQVIA, which was contracted by Johnson & Johnson for the presented analyses. J.W. served as a member of the board of directors or advisory committees at AbbVie. All other authors have nothing to declare.

Figures

Fig. 1
Fig. 1
Change from baseline in EORTC QLQ-C30 GHS score. EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item; GHS, Global Health Status; LS, least squares; CI, confidence interval; D-VMP, daratumumab plus bortezomib/melphalan/prednisone; VMP, bortezomib/melphalan/prednisone; ISS, International Staging System. LS means are derived based on the mixed-effects model with repeated measures, in which the dependent variable is change from baseline in score, and independent variables are baseline, visit, treatment, visit by treatment interaction, and randomization stratification factors—ISS staging (I, II, III) and age (< 75 years vs. ≥ 75 years)—as fixed effects and individual patient as random effect
Fig. 2
Fig. 2
Change from baseline in EORTC QLQ-C30 functional domain scores for a) physical functioning, b) role functioning, c) emotional functioning, d) cognitive functioning, and e) social functioning. EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item; LS, least squares; CI, confidence interval; D-VMP, daratumumab plus bortezomib/melphalan/prednisone; VMP, bortezomib/melphalan/prednisone; ISS, International Staging System. LS means are derived based on the mixed-effects model with repeated measures, in which the dependent variable is change from baseline in score, and independent variables are baseline, visit, treatment, visit by treatment interaction, and randomization stratification factors—ISS staging (I, II, III) and age (< 75 years vs. ≥ 75 years)—as fixed effects and individual patient as random effect
Fig. 3
Fig. 3
Change from baseline in EORTC QLQ-C30 symptom domain scores for a) pain, b) fatigue, and c) nausea and vomiting. EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item; LS, least squares; CI, confidence interval; D-VMP, daratumumab plus bortezomib/melphalan/prednisone; VMP, bortezomib/melphalan/prednisone; ISS, International Staging System. LS means are derived based on the mixed-effects model with repeated measures, in which the dependent variable is change from baseline in score, and independent variables are baseline, visit, treatment, visit by treatment interaction, and randomization stratification factors—ISS staging (I, II, III) and age (< 75 years vs. ≥ 75 years)—as fixed effects and individual patient as random effect
Fig. 4
Fig. 4
Percentage of patients reporting clinically meaningful improvement in EORTC QLQ-C30 GHS, functional, and symptom scales at 24 months. EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item; GHS, Global Health Status; D-VMP, daratumumab plus bortezomib/melphalan/prednisone; VMP, bortezomib/melphalan/prednisone. Clinically meaningful improvement was defined as ≥ 10-point improvement from the baseline score. No. of patients is the number of patients with a minimally important difference in each treatment group
Fig. 5
Fig. 5
EQ-5D-5L results for a) change from baseline in VAS score, b) change from baseline in utility score, and c) the percentage of patients reporting clinically meaningful improvement in VAS score over 24 months. EQ-5D-5L, EuroQol 5-dimensional descriptive system; VAS, visual analog scale; LS, least squares; CI, confidence interval; D-VMP, daratumumab plus bortezomib/melphalan/prednisone; VMP, bortezomib/melphalan/prednisone; ISS, International Staging System. LS means are derived based on the mixed-effects model with repeated measures, in which the dependent variable is change from baseline in score, and independent variables are baseline, visit, treatment, visit by treatment interaction, and randomization stratification factors—ISS staging (I, II, III) and age (< 75 years vs. ≥ 75 years)—as fixed effects and individual patient as random effect. Clinically meaningful improvement was defined as ≥ 7-point improvement from the baseline score. No. of patients is the number of patients with VAS results in each treatment group at each time point
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