Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.

Nantes University Hospital2 sites in 1 country48 target enrollmentMay 19, 2014

ConditionsMultiple Myeloma in Older Patients

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Myeloma in Older Patients
Sponsor: Nantes University Hospital
Enrollment: 48
Locations: 2
Primary Endpoint: The occurrence of the events
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 19, 2014

End Date

November 28, 2018

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The occurrence of the events

Time Frame: 6 MONTHS

The primary outcome is either : * early interruption of treatment * dose reduction \> 20% during treatment * discontinuous treatment These outcomes will be measured every 6 months during the 2 years of follow up