Impact of elotuzumab treatment on pain and health-related quality of life in patients with relapsed or refractory multiple myeloma: results from the ELOQUENT-2 study

Abstract

Treatment of relapsed/refractory multiple myeloma (RRMM) aims to prolong survival while maintaining health-related quality of life (HRQoL) by managing disease-related symptoms and complications-one of the most frequent and debilitating being bone pain. In the ELOQUENT-2 study (NCT01239797), which evaluated the addition of elotuzumab to lenalidomide plus dexamethasone versus lenalidomide plus dexamethasone, pain and HRQoL were assessed in patients with relapsed/refractory disease using the Brief Pain Inventory-Short Form (BPI-SF) and the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 module (QLQ-C30) and myeloma-specific module (QLQ-MY20). Mean baseline pain scores were low and remained so throughout treatment with both regimens; mean HRQoL scores did not change substantially from baseline. A significantly higher proportion of patients with objective response than without had clinically meaningful improvements in worst pain over two consecutive treatment cycles (29 versus 12%; p < 0.001). Patients with very good partial response (VGPR) or better reported reduced scores for pain severity and worst pain; those with progressive disease reported increased scores for these domains and pain interference. These findings show that previously reported improvements in progression-free survival and response rate with elotuzumab are achieved without detriment to HRQoL, which is maintained over time.

Keywords: Health-related quality of life; Multiple myeloma; Pain; Patient-reported outcomes.

Conflict of interest statement

Conflict of interest

David Cella has served as a consultant for and/or received research funding from AbbVie, Alexion, Astellas, Bayer, Biogen Idec, Bristol-Myers Squibb, Celgene, Clovis Oncology, Daiichi Sankyo, Eli Lilly, Evidera, Exelixis, FibroGen, Genentech, GlaxoSmithKline, Helsinn Therapeutics, Immunogen, Ipsen Pharma, Janssen, Lexicon Pharmaceuticals, Merck, Novartis, Onconova, and Pfizer. Jan McKendrick and Amber Kudlac are employees of PRMA Consulting Ltd. Antonio Palumbo has received honoraria from Amgen, Bristol-Myers Squibb, Celgene, Genmab, Janssen-Cilag, Millennium, Novartis, Onyx, and Sanofi, and served in a consulting or advisory role for Amgen, Bristol-Myers Squibb, Celgene, Genmab, Janssen-Cilag, Millennium, and Onyx. Abderrahim Oukessou, Teresa Zyczynski, and Catherine Davis are employees of Bristol-Myers Squibb. Ravi Vij has received honoraria from Bristol-Myers Squibb, Celgene, Janssen, Merck, Novartis, Onyx, and Takeda; served in a consulting or advisory role for Bristol-Myers Squibb, Celgene, Janssen, Merck, Novartis, Onyx, and Takeda; received research funding from Onyx and Takeda; and received travel, accommodations, and/or expenses from Bristol-Myers Squibb, Celgene, Janssen, Merck, Novartis, Onyx, and Takeda.

Figures

Fig. 1

Patient-reported pain severity during treatment: mean absolute values by treatment. The dashed line indicates ELd elotuzumab, lenalidomide, and dexamethasone, EOS end of study visit, Ld lenalidomide and dexamethasone

Fig. 2

Patient-reported pain severity during treatment, by age group: mean absolute values in patients p < 0.05) for the difference between treatments in the <65 years age group; daggers (†) denote statistical significance (p < 0.05) for the difference between treatments in the ≥65 years age group. ELd elotuzumab, lenalidomide, and dexamethasone, EOS end of study visit, Ld lenalidomide and dexamethasone

Fig. 3

Patient-reported pain severity during treatment, by baseline score: mean absolute values in patient subgroups with (score ≥ 5) or without (score p < 0.05) for the difference between treatments in the subgroup with a pain severity score ≥ 5. ELd elotuzumab, lenalidomide, and dexamethasone, EOS end of study visit, Ld lenalidomide and dexamethasone

Fig. 4

Pain response during treatment, by clinical response: cumulative percentage of patients with a sustained improvement in worst pain among those who achieved, or did not achieve, an objective response to treatment in the overall population. OR objective response

Fig. 5

Patient-reported pain during treatment, by best response to treatment: mean change from baseline in pain severity in patients with a best response to treatment of at least a VGPR, less than a VGPR, or progressive disease. ELd elotuzumab, lenalidomide, and dexamethasone, Ld lenalidomide and dexamethasone, PD progressive disease, VGPR very good partial response