Comparison of Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients

Completed

• Conditions: Multiple Myeloma; Hematologic Diseases

• Registration Number: NCT02918695
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-29
• Study Start: 2017-04-07
• Primary Completion: 2021-02-02
• Study Completion: 2021-02-02
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• newly diagnosed multiple myeloma
• age => 70 years
• no previous anti-myeloma treatment except for local radiotherapy or short course (max 4 days) of high-dose dexamethasone
• signed informed consent
• patients included in an interventional therapeutic trial are eligible

Exclusion Criteria

• previous systemic anti-myeloma treatment
• severe mental or cognitive disorder precluding geriatric assessment
• patient refusal to sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the geriatric categorization (fit versus frail) by standard clinical assessment versus by geriatric scoring.	At baseline	Comparison of geriatric categorization by standard clinical assessment (fit versus frail ) versus by geriatric scoring ( G8 score, CGA (Comprehensive Geriatric Assessment) and IMWG score will result in fit or frail) will be presented in proportion of agreement (accuracy, specificity, sensitivity, positive predictive value, negative predictive value).

Secondary Outcome Measures

Name	Time	Method
Treatment discontinuation	Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.
Change in geriatric categorization (fit versus frail) by CGA from baseline to time of first relapse of multiple myeloma	At first relapse of multiple myeloma, defined according to IMWG criteria (ref. Durie et al. Leukemia 2006)
Overall survival	Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.
Comparison of the geriatric categorization (fit versus frail) by CGA versus by IMWG scoring	At baseline	The results will be presented in terms of accuracy, specificity, sensitivity, positive predictive value, negative predictive value.
Description of the causes for dose-reduction and/or treatment discontinuation	Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.
Change in geriatric categorization (fit versus frail) by CGA from baseline to 3 months of anti-myeloma therapy.	after 3 months of anti-myeloma treatment
Description of geriatric problems detected by CGA ( unknown items assessed by validated CGA scoring tool)(ref. Kenis et al. An of Onc 2013;24:1306)	At baseline
Response rate	Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.
Progression free survival	Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.
Treatment-related deaths	Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.
Grade 3 and 4 non-hematological and grade 4 hematological adverse events (according to CTCAE 4.0)	Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.
Dose reductions of anti-myeloma treatment	Up to 1 year after signing the informed consent, or until disease progression, until anti-myeloma treatment discontinuation, until withdrawal of informed consent, until death or loss to follow-up, whichever occurs first.

Trial Locations

Locations (20)

ZNA Antwerpen; 🇧🇪 Antwerpen, Belgium

Centre Hospitalier EpiCURA; 🇧🇪 Baudour, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

AZ Klina; 🇧🇪 Brasschaat, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

UZ Brussel; 🇧🇪 Brussels, Belgium

Cliniques Universitaires Saint-Luc; 🇧🇪 Brussels, Belgium

GHdC Charlerloi; 🇧🇪 Charleroi, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Ziekenhuis Oost-Limburg (ZOL); 🇧🇪 Genk, Belgium

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