Clinical trial · Interventional
Vulnerability and Therapeutic Changes in Older Patients With Multiple Myeloma.
NCT02063113CI-TRIAL-00066615MYELOME-PAterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): inclusion difficulty
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma in Older Patients | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vulnerability and therapeutic changes in older patients with multiple myeloma. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- NA/NA
- interventionNames
- Other: Vulnerability and therapeutic changes in older patients with multiple myeloma.
Primary outcomes (1)
- measure
- The occurrence of the events
- timeFrame
- 6 MONTHS
- 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
Secondary outcomes (5)
- measure
- Type of Vulnerability
- timeFrame
- 6 MONTHS
- description
- vulnerability related to toxicities, vulnerability related to multiple myeloma or geriatric vulnerability.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.