Multiple Myeloma Clinical Trial
Official title:
Dynamic Frailty Assessment for Guiding the Treatment in Older Adults With Newly Diagnosed Multiple Myeloma :a Prospective and Single-center Study
Investigators designed the single-center, prospective real-world based clinical study with the aim of applying the standardized geriatric assessment system IMWG-FS internationally for dynamic frailty assessment of elderly newly diagnosed multiple myeloma(NDMM), guiding therapeutic decision based on their fit/frail status (fit → intensive; frail → mild), to observe their treatment tolerance, treatment related adverse events(TRAE), treatment discontinued(TD), and survival(progression survivaland overall survival).
A retrospective study from our center demonstrated that frailty is an important prognostic factor in elderly NDMM patients and is independent of age and myeloma biology with the ability to predict OS and EM. However, this retrospective study had missing patient baseline data and some patients did not receive standardized induction therapy. Therefore, based on the previous study, investigators designed a present prospective, multicenter, single-arm, observational clinical study. Based on the IMWG frailty score, this study incorporated the Karnofsky Performance Status Scale (KPS) , the Mini-Nutritional Assessment Short-form (MNA-SF) , the 15-item Geriatric Depression Scale (GDS-15) , walking speed, and objective biological indicators including NT-pro-BNP, CRP, and eGFR , a comprehensive geriatric assessment of elderly NDMM patients, and an analysis of the clinical characteristics of frail and elderly patients with multiple myeloma， with the aim of establishing a new and better geriatric and frailty assessment system for identifying frail patients and validating its predictive efficacy for survival in elderly NDMM patients. ;
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