Clinical trial NCT02918695: Comparison of Geriatric Screening Methods in Newly Diagnosed Multiple Myeloma Patients
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Hematologic Diseases
Keywords: Geriatric assessment
Fit and frail elderly
Geriatric oncology
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-09-29
Enrollment: 200
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 newly diagnosed elderly Multiple Myeloma patients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the geriatric categorization (fit versus frail) by standard clinical assessment versus by geriatric scoring.
timeFrame: At baseline
Secondary outcomes:
measure: Comparison of the geriatric categorization (fit versus frail) by CGA versus by IMWG scoring
timeFrame: At baseline
measure: Change in geriatric categorization (fit versus frail) by CGA from baseline to 3 months of anti-myeloma therapy.
timeFrame: after 3 months of anti-myeloma treatment
measure: Change in geriatric categorization (fit versus frail) by CGA from baseline to time of first relapse of multiple myeloma
timeFrame: At first relapse of multiple myeloma, defined according to IMWG criteria (ref. Durie et al. Leukemia 2006)
measure: 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)
timeFrame: At baseline
measure: Response rate
timeFrame: 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.
measure: Progression free survival
timeFrame: 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.
measure: Overall survival
timeFrame: 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.
measure: Treatment-related deaths
timeFrame: 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.
measure: Grade 3 and 4 non-hematological and grade 4 hematological adverse events (according to CTCAE 4.0)
timeFrame: 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.
measure: Treatment discontinuation
timeFrame: 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.
measure: Dose reductions of anti-myeloma treatment
timeFrame: 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.
measure: Description of the causes for dose-reduction and/or treatment discontinuation
timeFrame: 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.
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Antwerpen
city: Baudour
country: Belgium
facility: Centre Hospitalier EpiCURA
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: UZ Brussel
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Charleroi
country: Belgium
facility: GHdC Charlerloi
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg (ZOL)
city: Gent
country: Belgium
facility: UZ Gent
city: Haine-Saint-Paul
country: Belgium
facility: Hôpital de Jolimont
city: Ieper
country: Belgium
facility: Jan Yperman Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Lier
country: Belgium
facility: Heilig-Hartziekenhuis Lier
city: Liège
country: Belgium
facility: CHU de Liège
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Yvoir
country: Belgium
facility: CHU Dinant-Mont-Godinne
Study officials:
affiliation: UZ Leuven Gasthuisberg
name: Michel Delforge, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: