NCT02918695

Comparison of Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients

Comparison of Different Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients, and Assessment of Therapeutic Efficacy and Toxicity in Fit and Frail Patients. A Multicenter Observational Belgian Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare clinical judgment and comprehensive geriatric assessment as screening tools for optimization of treatment for newly diagnosed elderly multiple myeloma patients.

Detailed description

Given the growing elderly multiple myeloma population, the increase in therapeutic possibilities and the importance of geriatric screening, this study wants: * to compare clinical judgment with standardized geriatric screening approaches (G8, CGA and IMWG score) in newly diagnosed elderly myeloma patients and to evaluate their influence on the detection of geriatric problems and on the choice of the anti-myeloma treatment * to evaluate how geriatric scoring and the subsequent treatment choice influences the therapeutic efficacy and toxicities Geriatric scoring will be performed in 3 different ways: * by clinical judgment performed by the treating physician * by validated scoring systems independently performed by a trained nurse/ health care worker. Initial scoring will be done by the G8 score. If an abnormal G8 score is present (\<= 14), CGA will be performed. * based on the CGA parameters, the Palumbo/IMWG geriatric score will be calculated Results obtained by physician-based assessment and by geriatric assessment will be compared before treatment initiation. If, and to what extent the knowledge of the GA influences the therapeutic decision of the treating physician will be registered. In addition, we will register which geriatric problems diagnosed by the CGA assessment were already known or unknown by the treating physician. After three months of treatment and at the time of disease progression, geriatric assessment will be repeated in order to judge the evolution (disappearance, improvement, worsening) of the scored parameters, or the emergence of new geriatric symptoms.

Conditions

• Multiple Myeloma
• Hematologic Diseases

Timeline

• Start date: 2017-04-07
• Primary completion: 2021-02-02
• Completion: 2021-02-02
• First posted: 2016-09-29
• Last updated: 2021-05-04

Locations

20 sites across 1 country: Belgium