There are limited real-world longitudinal data on effects of initial tx on HRQoL in NDMM. Connect MM is a US multicenter, prospective observational cohort study designed to examine diagnostic & tx patterns, clinical outcomes & HRQoL in pts with NDMM. The aim of this analysis was to assess the role of initial tx on changes in HRQoL & outcomes in NDMM pts without intent for immediate SCT, comparing some standard EU tx regimens vs a US standard of care (lenalidomide-bortezomib-dexamethasone; RVd).
3011 NDMM pts enrolled from 250 sites; HRQoL questionnaires & clinical assessments were conducted at study baseline & quarterly (Q) until death or discontinuation (D/C). Changes in HRQoL assessments during Q1-4 of initial tx & survival outcomes (PFS & OS), adjusted for covariates through a propensity score, were examined for comparator groups: RVd vs VMP (bortezomib-melphalan-prednisone) & RVd vs Vd or VMP. Untreated pts (n = 76) or those without HRQoL assessments (n = 58) were excluded. Pts were censored by data cut off (Jan 15, 2018), transition off initial tx, progressive disease, or D/C from study.
Analysis included 1037 pts (Table); pts with VTD (n = 20) not examined due to small number. Baseline characteristics & HRQoL assessment completion rates were generally similar among groups (eg EQ-5D at Q4: 67% - 80%). There were significantly higher HRQoL improvements with RVd vs Vd or VMP for FACT-MM MMS, EQ-5D overall, & BPAIN indices. Adjusted PFS & OS were significantly longer with Table: 1007O
|Changes in HRQoL Scores||RVd (n = 446) vs VMP (n = 77)||RVd (n = 446) vs Vd or VMP (n = 591)|
|Est. diff. (95% CI)||P value||Est. diff. (95% CI)||P value|
|Total||-.76 (-7.65, 6.13)||.83||3.00 (-.58, 6.58)||.10|
|TOI||.69 (-5.44, 6.82)||.82||2.11 (-.74, 4.97)||.15|
|MMS||1.92 (-1.29, 5.13)||.24||1.76 (.26, 3.26)||.02|
|EQ-5D overall||.004 (-.04, .05)||.87||.03 (.006, .05)||.02|
|BPAIN*||-1.29 (-2.12, -0.46)||.002||-.46 (-.82, -.09)||.02|
|Outcomes, median||RVd||VMP||P value; HR (95% CI)||RVd||Vd or VMP||P value; HR (95% CI)|
|PFS, mo||29.3||17.5||.0449; .71 (.51, .99)||27.3||19.4||.0003; .74 (.63, .87)|
|OS, mo||62.6||45.6||.0441; .67 (.45, .99)||60.0||44.4||.0027; .73 (.60, .90)|
Lower values indicate improved HRQoL, for all others higher values indicate improved HRQoL.RVd (Table).
In this analysis of the largest US MM registry, initial tx with more efficacious RVd shows no deterioration in longitudinal HRQoL vs VMP or Vd, regimens commonly used as initial tx in the EU, & significant improvements in survival. These findings provide meaningful real-world evidence on the effects of initial tx choice on HRQoL & outcomes among pts with NDMM without intent for immediate SCT.
Clinical trial identification
Legal entity responsible for the study
The authors received editorial support from Maryann Obiorah, PhD, of Bio Connections, in the preparation of this abstract, which was funded by Celgene Corporation.
R. Abonour: Steering committee and research funding: Celgene, Takeda; Research funding: Prothena. R.M. Rifkin: Consultancy: Amgen, Boehringer Ingelheim, Celgene, EMD Serono, Sandoz, Takeda; Stock: McKesson. C. Gasparetto: Honoraria: Janssen, BMS, Celgene, Takeda; Consultancy: Janssen, BMS, Celgene; Travel, accommodations or other expenses: Janssen, BMS, Celgene; Research funding: Celgene. K. Toomey: Consultancy: Celgene; Speaker’s bureau: Myriad Genetics; Travel: Dava Oncology. B.G.M. Durie: Consultancy: Takeda, Janssen. J.W. Hardin: Consultancy: Celgene. H.R. Terebelo: Consultancy: Celgene; Speaker’s bureau: Janssen, Takeda, Pharmacyclics, S. Jagannath: Consultancy: Celgene, BMS, Novartis, Merck; Speaker’s bureau: MMRF, Medicom. M. Narang: Consultancy and speaker’s bureau: Celgene; Speaker’s bureau: Janssen. S. Ailawadhi: Consultant's fees: Takeda, Novartis, Celgene, Amgen; Research support: Pharmacyclics. S. Srinivasan, A. Kitali, A. Agarwal: Employment: Celgene. L. Wagner: Consultancy: EveryFit, Gilead, Janssen.