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

Primary Purpose

Multiple Myeloma in Older Patients

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vulnerability and therapeutic changes in older patients with multiple myeloma.
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Myeloma in Older Patients focused on measuring Multiple myeloma,, Older patient,, Treatment,, Geriatric assessment

Eligibility Criteria

70 Years - 100 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHD Vendée La Roche sur Yon
  • CHU de Nantes

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

NA/NA

Arm Description

Outcomes

Primary Outcome Measures

The occurrence of the events
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

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

Full Information

First Posted
February 11, 2014
Last Updated
May 22, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02063113
Brief Title
Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.
Acronym
MYELOME-PA
Official Title
Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
inclusion difficulty
Study Start Date
May 19, 2014 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma in Older Patients
Keywords
Multiple myeloma,, Older patient,, Treatment,, Geriatric assessment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NA/NA
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Vulnerability and therapeutic changes in older patients with multiple myeloma.
Primary Outcome Measure Information:
Title
The occurrence of the events
Description
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
Time Frame
6 MONTHS
Secondary Outcome Measure Information:
Title
Type of Vulnerability
Description
vulnerability related to toxicities, vulnerability related to multiple myeloma or geriatric vulnerability.
Time Frame
6 MONTHS
Title
Therapeutic changes
Description
early interruption of treatment, dose reduction during treatment, discontinuous treatment
Time Frame
6 MONTHS
Title
Toxicity during treatment
Description
hematologic toxicity, neurotoxicity, gastrointestinal toxicity, deep vein thrombosis, pulmonary embolism, infections with antibiotic use
Time Frame
6 months
Title
Progression to 1 and 2 years
Time Frame
1 year/2year
Title
Complete response at 1 and 2 years
Time Frame
1 year/2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Komivi AGBETSIVI, DR
Organizational Affiliation
CHD Vendée La Roche sur Yon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
VIGNARD Patricia, Dr
Organizational Affiliation
CH du Mans
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Cattenoz, Dr
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean -Richard EVEILLARD, Dr
Organizational Affiliation
CHU de Brest
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François Puisieux, Pr
Organizational Affiliation
CHU de Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean -Yves NIEMIER, Dr
Organizational Affiliation
CHU de Nancy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frédérique Retornaz, Dr
Organizational Affiliation
CGD de Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Véronique Brunel, Dr
Organizational Affiliation
Hôpital Européen de Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laure De Decker, Dr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHD Vendée La Roche sur Yon
City
La Roche-sur-Yon
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

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Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.

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