Impact of post-transplantation maintenance therapy on health-related quality of life in patients with multiple myeloma: data from the Connect® MM Registry

Rafat Abonour, Lynne Wagner, Brian G M Durie, Sundar Jagannath, Mohit Narang, Howard R Terebelo, Cristina J Gasparetto, Kathleen Toomey, James W Hardin, Amani Kitali, Craig J Gibson, Shankar Srinivasan, Arlene S Swern, Robert M Rifkin, Rafat Abonour, Lynne Wagner, Brian G M Durie, Sundar Jagannath, Mohit Narang, Howard R Terebelo, Cristina J Gasparetto, Kathleen Toomey, James W Hardin, Amani Kitali, Craig J Gibson, Shankar Srinivasan, Arlene S Swern, Robert M Rifkin

Abstract

Maintenance therapy after autologous stem cell transplantation (ASCT) is recommended for use in multiple myeloma (MM); however, more data are needed on its impact on health-related quality of life (HRQoL). Presented here is an analysis of HRQoL in a Connect MM registry cohort of patients who received ASCT ± maintenance therapy. The Connect MM Registry is one of the earliest and largest, active, observational, prospective US registry of patients with symptomatic newly diagnosed MM. Patients completed the Functional Assessment of Cancer Therapy-MM (FACT-MM) version 4, EuroQol-5D (EQ-5D) questionnaire, and Brief Pain Inventory (BPI) at study entry and quarterly thereafter until death or study discontinuation. Patients in three groups were analyzed: any maintenance therapy (n = 244), lenalidomide-only maintenance therapy (n = 169), and no maintenance therapy (n = 137); any maintenance and lenalidomide-only maintenance groups were not mutually exclusive. There were no significant differences in change from pre-ASCT baseline between any maintenance (P = 0.60) and lenalidomide-only maintenance (P = 0.72) versus no maintenance for the FACT-MM total score. There were also no significant differences in change from pre-ASCT baseline between any maintenance and lenalidomide-only maintenance versus no maintenance for EQ-5D overall index, BPI, FACT-MM Trial Outcomes Index, and myeloma subscale scores. In all three groups, FACT-MM, EQ-5D Index, and BPI scores improved after ASCT; FACT-MM and BPI scores deteriorated at disease progression. These data suggest that post-ASCT any maintenance or lenalidomide-only maintenance does not negatively impact patients' HRQoL. Additional research is needed to verify these findings.

Keywords: Community medicine; Multiple myeloma; Quality of life; Registry; Stem cell transplantation.

Conflict of interest statement

Conflicts of interest

Rafat Abonour: Steering committee for Celgene, research funding from Celgene, Takeda, and Prothena; Lynne Wagner: consultancy for EveryFit, Gilead, and Janssen; Brian G. M. Durie: consultancy for Takeda and Janssen; Sundar Jagannath: consultancy for Bristol-Myers Squibb, Celgene, Merck, and Novartis, speakers’ bureau for MMRF and Medicom; Mohit Narang: consultancy and speakers’ bureau for Celgene, speakers’ bureau for Janssen; Howard R. Terebelo: consultancy for Celgene, speakers’ bureau for Janssen, Takeda, and Pharmacyclics; Cristina J. Gasparetto: consultancy for Celgene, Janssen, and Bristol-Myers Squibb research funding from Celgene, honoraria from Bristol-Myers Squibb, Celgene, Takeda, and Janssen, travel reimbursement from Janssen, Bristol-Myers Squibb, and Celgene; Kathleen Toomey: consultancy for Celgene, speakers’ bureau for Myriad Genetics, travel reimbursement from Dava Oncology; James W. Hardin: consultancy for Celgene; Amani Kitali: employment at Celgene; Craig Gibson: employment at Celgene (former); Shankar Srinivasan: employment at Celgene; Arlene S. Swern: employment at Celgene; Robert M. Rifkin: consultancy for Amgen, Boehringer Ingelheim, Celgene, EMD Serono, Sandoz, and Takeda, stock with McKesson.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Figures

Fig. 1
Fig. 1
Connect MM HRQoL analysis design. Autologous stem cell transplant (ASCT), EuroQol Research Foundation EQ-5D questionnaire (EQ-5D), Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM); health-related quality of life (HRQoL), lenalidomide (LEN), progressive disease (PD)
Fig. 2
Fig. 2
Patient disposition. Autologous stem cell transplant (ASCT), lenalidomide (LEN). aPatients were excluded if they received allogenic or unknown stem cell transplant (SCT), tandem SCT, or consolidation before maintenance in course 1 or if they received SCT after first progression
Fig. 3
Fig. 3
FACT-MM total score change from pre-ASCT baseline (adjusted) values. FACT-MM total score scale is 0 to 164. a Any maintenance therapy (solid line) versus no maintenance therapy (dashed line). b Lenalidomide-only maintenance therapy (solid line) versus no maintenance therapy (dashed line). c HRQoL at baseline, pre-ASCT, during follow-up, and at PD. Autologous stem cell transplant (ASCT), Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM), health-related quality of life (HRQoL), lenalidomide (LEN), least-squares (LS), progressive disease (PD)..aLS mean during the analysis period, b66 patients had PD
Fig. 4
Fig. 4
FACT-MM TOI change from pre-ASCT baseline values (adjusted). FACT-MM TOI scale is 0 to 112. a Any maintenance therapy (solid line) versus no maintenance therapy (dashed line). b Lenalidomide-only maintenance therapy (solid line) versus no maintenance therapy (dashed line). c HRQoL at baseline, pre-ASCT, during follow-up, and at PD P values are paired t test comparisons between periods within treatment group. The TOI is the sum of the physical well-being, functional well-being, and “additional concerns” subscores. Autologous stem cell transplant (ASCT), Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM), health-related quality of life (HRQoL), lenalidomide (LEN), least-squares (LS), progressive disease (PD), trial outcome index (TOI). aLS mean during the analysis period, b66 patients had PD, c45 patients had PD, d44 patients had PD
Fig. 5
Fig. 5
FACT-MM MM subscale change from pre-ASCT baseline values (adjusted). FACT-MM MM subscale is 0 to 56. a Any maintenance therapy (solid line) versus no maintenance therapy (dashed line). b lenalidomide-only maintenance therapy (solid line) versus no maintenance therapy (dashed line). c HRQoL at baseline, pre-ASCT, during follow-up, and at PD. P values are paired t.test comparisons between periods within treatment group. Autologous stem cell transplant (ASCT), Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM), health-related quality of life (HRQoL), lenalidomide (LEN), least-squares (LS), progressive disease (PD). aLS mean during the analysis period. b66 patients had PD. c45 patients had PD. d44 patients had PD
Fig. 6
Fig. 6
EQ-5D overall index score change from pre-ASCT baseline values (adjusted). EQ-5D score scale is − 0.109 to 1. a Any maintenance therapy versus no maintenance therapy. b Lenalidomide-only maintenance therapy versus no maintenance therapy. c HRQoL at baseline, pre-ASCT, during follow-up, and at PD. P values are paired t test comparisons between periods within treatment group. Autologous stem cell transplant (ASCT), EuroQol Research Foundation questionnaire (EQ-5D), lenalidomide (LEN), least-squares (LS), progressive disease (PD). aLS mean during the analysis period, b44 patients in the LEN-only maintenance group had PD

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