Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.

Not Applicable

Terminated

• Conditions: Multiple Myeloma in Older Patients
• Interventions: Other: Vulnerability and therapeutic changes in older patients with multiple myeloma.

• Registration Number: NCT02063113
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Study Start: 2014-05-19
• Primary Completion: 2018-11-28
• Study Completion: 2018-11-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NA/NA	Vulnerability and therapeutic changes in older patients with multiple myeloma.	-

Primary Outcome Measures

Name	Time	Method
The occurrence of the events	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

Secondary Outcome Measures

Name	Time	Method
Progression to 1 and 2 years	1 year/2year
Type of Vulnerability	6 MONTHS	vulnerability related to toxicities, vulnerability related to multiple myeloma or geriatric vulnerability.
Therapeutic changes	6 MONTHS	early interruption of treatment, dose reduction during treatment, discontinuous treatment
Toxicity during treatment	6 months	hematologic toxicity, neurotoxicity, gastrointestinal toxicity, deep vein thrombosis, pulmonary embolism, infections with antibiotic use
Complete response at 1 and 2 years	1 year/2 years

Trial Locations

Locations (2)

CHD Vendée La Roche sur Yon; 🇫🇷 La Roche-sur-Yon, France

CHU de Nantes; 🇫🇷 Nantes, France