Clinical trial · Observational
Patient and Care Partner Experiences Living With Multiple Myeloma (PaCE-MM)
NCT05276622CI-TRIAL-00083680PaCE-MMterminatedClinicalTrials.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): Investigator left the institution.
Summary
Brief summary (as posted)
This research study is explore the impact over time of multiple myeloma and its associated treatments on the physical and cognitive function and quality of life of patients and their care partners and how these impacts affect the overall illness experience.
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 | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehensive Geriatric Assessment | Other | — | UNRESOLVED |
| Qualitative patient-care partner interviews | Other | — | UNRESOLVED |
| Surveys on well-being and function | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Subjects with newly diagnosed multiple myeloma
- description
- Forty subjects with newly diagnosed multiple myeloma.
- interventionNames
- Other: Comprehensive Geriatric Assessment
- label
- Care partners of the subjects with newly diagnosed multiple myeloma
- description
- Thirty care partners of the subjects with newly diagnosed multiple myeloma.
- interventionNames
- Other: Qualitative patient-care partner interviews
- Other: Surveys on well-being and function
Primary outcomes (6)
- measure
- Trajectories of cognitive functions NIHTB-CB
- timeFrame
- Up to 6 months
- description
- Standardized National Institutes of Health Toolbox Cognition Battery (objective) (NIHTB-CB) will be used for the measure of cognitive function. The NIHTB-CB contains 7 computer-based instruments assessing 5 cognitive sub-domains: Language, Executive Function, Episodic Memory, Processing Speed, and Working Memory. The Composite Score is calculated using all subsets. Higher score =better level of cognitive functions.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: Patients must meet the following inclusion criteria to participate in this study: 1. Aged ≥55 2. New myeloma diagnosis as defined by the International Myeloma Working Group, does not have another non-myeloma plasma cell disorder such as POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, skin changes) or amyloidosis. 3. Starting systemic treatment. 4. Able to understand and speak in English. 5. Able to provide informed consent to participate. Care Partners must meet the following inclusion criteria to participate in this study 1. Aged ≥18. 2. Able to understand and speak in English. 3. Able to provide informed consent to participate. 4. Be a care partner for a patient with multiple myeloma and is also enrolled in the assessment portion of this study. 5. Willing and able to participate in semi-structured interviews. Exclusion Criteria: 1. All participants meeting any of the following exclusion criteria at enrollment will be excluded from the study: Inability to read and speak English. 2. Dementia altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.