Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-02 @ 3:02 PM
Study NCT ID:
NCT02918695
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2016-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPASS
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: