Multiple Myeloma in Older Patients
Conditions
Keywords
Multiple myeloma,, Older patient,, Treatment,, Geriatric assessment
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.
Interventions
OTHERVulnerability and therapeutic changes in older patients with multiple myeloma.
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Progression to 1 and 2 years | 1 year/2year | — |
| Complete response at 1 and 2 years | 1 year/2 years | — |
Countries
France
Outcome results
None listed