Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.

Study Overview
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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.

Official Title
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Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.

Conditions
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Multiple Myeloma in Older Patients

Intervention / Treatment
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* Other: Vulnerability and therapeutic changes in older patients with multiple myeloma.


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 MONTHS | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple myeloma,, Older patient,, Treatment,, Geriatric assessment