Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial
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Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial. / Perrot, Aurore; Facon, Thierry; Plesner, Torben; Usmani, Saad Z; Kumar, Shaji; Bahlis, Nizar J; Hulin, Cyrille; Orlowski, Robert Z; Nahi, Hareth; Mollee, Peter; Ramasamy, Karthik; Roussel, Murielle; Jaccard, Arnaud; Delforge, Michel; Karlin, Lionel; Arnulf, Bertrand; Chari, Ajai; He, Jianming; Ho, Kai Fai; Van Rampelbergh, Rian; Uhlar, Clarissa M; Wang, Jianping; Kobos, Rachel; Gries, Katharine S; Fastenau, John; Weisel, Katja.
In: J CLIN ONCOL, Vol. 39, No. 3, 20.01.2021, p. 227-237.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial
AU - Perrot, Aurore
AU - Facon, Thierry
AU - Plesner, Torben
AU - Usmani, Saad Z
AU - Kumar, Shaji
AU - Bahlis, Nizar J
AU - Hulin, Cyrille
AU - Orlowski, Robert Z
AU - Nahi, Hareth
AU - Mollee, Peter
AU - Ramasamy, Karthik
AU - Roussel, Murielle
AU - Jaccard, Arnaud
AU - Delforge, Michel
AU - Karlin, Lionel
AU - Arnulf, Bertrand
AU - Chari, Ajai
AU - He, Jianming
AU - Ho, Kai Fai
AU - Van Rampelbergh, Rian
AU - Uhlar, Clarissa M
AU - Wang, Jianping
AU - Kobos, Rachel
AU - Gries, Katharine S
AU - Fastenau, John
AU - Weisel, Katja
PY - 2021/1/20
Y1 - 2021/1/20
N2 - 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.
AB - 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.
U2 - 10.1200/JCO.20.01370
DO - 10.1200/JCO.20.01370
M3 - SCORING: Journal article
C2 - 33326255
VL - 39
SP - 227
EP - 237
JO - J CLIN ONCOL
JF - J CLIN ONCOL
SN - 0732-183X
IS - 3
ER -
