Multiple Myeloma in Older Patients Clinical Trial
— MYELOME-PAOfficial title:
Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.
| Verified date | May 2023 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 48 |
| Est. completion date | November 28, 2018 |
| Est. primary completion date | November 28, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 70 Years to 100 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHD Vendée La Roche sur Yon | La Roche-sur-Yon | |
| France | CHU de Nantes | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Type of Vulnerability | vulnerability related to toxicities, vulnerability related to multiple myeloma or geriatric vulnerability. | 6 MONTHS | |
| Secondary | Therapeutic changes | early interruption of treatment, dose reduction during treatment, discontinuous treatment | 6 MONTHS | |
| Secondary | Toxicity during treatment | hematologic toxicity, neurotoxicity, gastrointestinal toxicity, deep vein thrombosis, pulmonary embolism, infections with antibiotic use | 6 months | |
| Secondary | Progression to 1 and 2 years | 1 year/2year | ||
| Secondary | Complete response at 1 and 2 years | 1 year/2 years |