Comparison of Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients
NCT ID: NCT02918695
Last Updated: 2021-05-04
Study Results
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Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2017-04-07
2021-02-02
Brief Summary
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Detailed Description
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* 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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* severe mental or cognitive disorder precluding geriatric assessment
* patient refusal to sign informed consent
70 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Michel Delforge, MD PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven Gasthuisberg
Locations
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ZNA Antwerpen
Antwerp, , 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
UZ Gent
Ghent, , Belgium
Hôpital de Jolimont
Haine-Saint-Paul, , Belgium
Jan Yperman Ziekenhuis
Ieper, , Belgium
AZ Groeninge
Kortrijk, , Belgium
CHU Tivoli
La Louvière, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Heilig-Hartziekenhuis Lier
Lier, , Belgium
CHU de Liège
Liège, , Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
CHU Dinant-Mont-Godinne
Yvoir, , Belgium
Countries
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Other Identifiers
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NA-NI-MM-PI-006760
Identifier Type: -
Identifier Source: org_study_id
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