Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.

NCT ID: NCT02063113

Last Updated: 2023-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-19

Study Completion Date

2018-11-28

Brief Summary

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The aim of this study is to determine whether the presence of vulnerability detected by geriatricians is associated with treatment discontinuation in older patient. During the comprehensive geriatric assessment realized before the decision-treatment, the following data are recorded and their impact in the therapeutic changes will also be analysed: comorbidity, age, depression, functional status, the cognitive impairment and malnutrition.

Detailed Description

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Conditions

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Multiple Myeloma in Older Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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NA/NA

Group Type NO_INTERVENTION

Vulnerability and therapeutic changes in older patients with multiple myeloma.

Intervention Type OTHER

Interventions

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Vulnerability and therapeutic changes in older patients with multiple myeloma.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged 70 years and older
* Patients referred for a assessment of a newly diagnosed multiple myeloma
* Patients for who the initial therapy proposed is either melphalan-prednisone-thalidomide or melphalan-prednisone-bortezomib or included in a phase 3 trial.
* Patients who provide informed written consent

Exclusion Criteria

* Patients who refuse the study
* Patients who won't have therapy
* Patients can't respond to geriatric assessment because of severe cognitive disorder
* Patients with a legal guardian
Minimum Eligible Age

70 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Komivi AGBETSIVI, DR

Role: PRINCIPAL_INVESTIGATOR

CHD Vendée La Roche sur Yon

VIGNARD Patricia, Dr

Role: PRINCIPAL_INVESTIGATOR

CH du Mans

Catherine Cattenoz, Dr

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Jean -Richard EVEILLARD, Dr

Role: PRINCIPAL_INVESTIGATOR

CHU de Brest

François Puisieux, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU de Lille

Jean -Yves NIEMIER, Dr

Role: PRINCIPAL_INVESTIGATOR

Central Hospital, Nancy, France

Frédérique Retornaz, Dr

Role: PRINCIPAL_INVESTIGATOR

CGD de Marseille

Véronique Brunel, Dr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Européen de Marseille

Laure De Decker, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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CHD Vendée La Roche sur Yon

La Roche-sur-Yon, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC13_0437

Identifier Type: -

Identifier Source: org_study_id

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