Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma

Abstract

In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients. Here, we report health-related quality of life (HRQoL) results from this trial. Patients received PVd or Vd in 21-day cycles until disease progression or discontinuation. HRQoL was assessed using the EORTC QLQ-C30, QLQ-MY20, and EQ-5D-3L instruments on day 1 of each treatment cycle. Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms. The proportion of patients who experienced clinically meaningful worsening in global QoL and other domains of interest was similar. These HRQoL results with PVd along with previously demonstrated improvement in PFS vs Vd continue to support its use in patients with RRMM.

Keywords:

• Quality of life
• HRQoL
• multiple myeloma
• pomalidomide
• bortezomib
• dexamethasone

Author contributions

All authors contributed to the acquisition, analysis and interpretation of data and provided full approval for publication.

Acknowledgements

• The authors thank the patients and their families, as well as all participating clinical investigators.

• Medical writing support was provided by Nora Tu, PharmD, and Stephen Gilliver, PhD, of Evidera and was funded by Bristol Myers Squibb.

Research availability of data and materials

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Disclosure statement

KW: advisory board for and honoraria from Amgen, Adaptive Biotech, Celgene, a Bristol Myers Squibb company, Bristol Myers Squibb, Janssen, Juno, Takeda, Sanofi and research funding from Amgen, Celgene, a Bristol Myers Squibb Company, Sanofi, Janssen; MD: honoraria, consulting fees, and lecture fees from Celgene, a Bristol Myers Squibb Company, Amgen, Takeda; PM: personal fees from Celgene, a Bristol Myers Squibb Company, Janssen; MY: nothing to disclose; AL: honoraria and personal fees from Amgen, honoraria, advisory board, and personal fees from Bristol Myers Squibb, Celgene, a Bristol Myers Squibb Company, Janssen, and advisory board for Takeda; ASK: nothing to disclose; FV: nothing to disclose; NC: nothing to disclose; SB: nothing to disclose; PJ: nothing to disclose; PB: stock ownership in Merck, Bristol Myers Squibb, Pfizer, Teva, Johnson & Johnson and honoraria from Merck, AstraZeneca; MH: nothing to disclose; PRO: personal fees, lectures, and advisory boards for Celgene, a Bristol Myers Squibb Company, Janssen and personal fees and advisory boards for Kite Pharma, AbbVie, Sanofi; EM: nothing to disclose; PA: nothing to disclose; PH: nothing to disclose; MTK: consultancy for and honoraria from Amgen, Bristol Myers Squibb, Celgene, a Bristol Myers Squibb Company, Takeda, Novartis, and Janssen; PL: advisory board for and honoraria from Amgen, Celgene, a Bristol Myers Squibb Company, Janssen, Takeda, Sanofi; DBY: nothing to disclose; LM: nothing to disclose; SG: consulting fees from Celgene, a Bristol Myers Squibb Company; XY: employee for and salary/compensation from Bristol Myers Squibb; LG: employment with Bristol Myers Squibb; TB: employment and equity ownership in Celgene International Sàrl, a Bristol Myers Squibb Company; SD: employment and equity ownership in Bristol Myers Squibb; PR: grants from Bristol Myers Squibb, grants and personal fees from Oncopeptides, Celgene, a Bristol Myers Squibb Company, Takeda, and personal fees from Karyopharm, Amgen, Janssen, Sanofi.

Additional information

Funding

This work was supported by Celgene Corporation, a Bristol Myers Squibb Company.