Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma. (MYELOME-PA)

May 22, 2023 updated by: Nantes University Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche-sur-Yon, France
        • CHD Vendée La Roche sur Yon
      • Nantes, France, 44000
        • CHU de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: NA/NA
Other: Vulnerability and therapeutic changes in older patients with multiple myeloma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 MONTHS

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Komivi AGBETSIVI, DR, CHD Vendée La Roche sur Yon
  • Principal Investigator: VIGNARD Patricia, Dr, CH du Mans
  • Principal Investigator: Catherine Cattenoz, Dr, Rennes University Hospital
  • Principal Investigator: Jean -Richard EVEILLARD, Dr, CHU de Brest
  • Principal Investigator: François Puisieux, Pr, CHU de Lille
  • Principal Investigator: Jean -Yves NIEMIER, Dr, CHU de Nancy
  • Principal Investigator: Frédérique Retornaz, Dr, CGD de Marseille
  • Principal Investigator: Véronique Brunel, Dr, Hôpital Européen de Marseille
  • Principal Investigator: Laure De Decker, Dr, CHU de Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2014

Primary Completion (Actual)

November 28, 2018

Study Completion (Actual)

November 28, 2018

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC13_0437

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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