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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02918695
Other study ID # NA-NI-MM-PI-006760
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 7, 2017
Est. completion date February 2, 2021

Study information

Verified date May 2021
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date February 2, 2021
Est. primary completion date February 2, 2021
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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


Locations

Country Name City State
Belgium ZNA Antwerpen Antwerpen
Belgium Centre Hospitalier EpiCURA Baudour
Belgium Imelda Ziekenhuis Bonheiden
Belgium AZ Klina Brasschaat
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium Institut Jules Bordet Brussels
Belgium UZ Brussel Brussels
Belgium GHdC Charlerloi Charleroi
Belgium Universitair Ziekenhuis Antwerpen Edegem
Belgium Ziekenhuis Oost-Limburg (ZOL) Genk
Belgium UZ Gent Gent
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 CHU de Liège Liège
Belgium Heilig-Hartziekenhuis Lier Lier
Belgium AZ Nikolaas Sint-Niklaas
Belgium CHU Dinant-Mont-Godinne Yvoir

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of the geriatric categorization (fit versus frail) by standard clinical assessment versus by geriatric scoring. 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). At baseline
Secondary Comparison of the geriatric categorization (fit versus frail) by CGA versus by IMWG scoring The results will be presented in terms of accuracy, specificity, sensitivity, positive predictive value, negative predictive value. At baseline
Secondary 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
Secondary 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)
Secondary 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
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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