Comparison of Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients

Multiple Myeloma Clinical Trial

— COMPASS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918695
• Other study ID #: NA-NI-MM-PI-006760
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hematologic Diseases
• Multiple Myeloma
• Neoplasms, Plasma Cell

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.