| Registry | NCT03508765 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 18 (Actual) |
| Sponsor | Memorial Sloan Kettering Cancer Center (Other) |
| Conditions | Multiple Myeloma |
| Interventions | Structural Image, Functional Image, Digit Span subtest, Brief Test of Attention, Trail Making Test (Parts A & B), Auditory Consonant Trigrams Test, Controlled Oral Word Association Test, Hopkins Verbal Learning Test-Revised, The Center for Epidemiological Study-Depression, The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4, Blood draw (Diagnostic test, behavioral, other) |
| Dates | start 2018-03-27, primary completion 2024-03-06, completion 2024-03-06, first posted 2018-04-26, last updated 2024-03-08 |
| Locations | 2 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Multiple Myeloma All trials of Structural Image All trials of Functional Image
The purpose of this study is to learn about possible changes in thinking (cognitive) abilities, such as memory skills, and in brain anatomy and function, in adults with multiple myeloma who are treated with high-dose chemotherapy followed by ASCT.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| rsfMRI + Neurocognitive Tests | Experimental | Diagnostic Test: Structural Image; Diagnostic Test: Functional Image; Behavioral: Digit Span subtest; Behavioral: Brief Test of Attention; Behavioral: Trail Making Test (Parts A & B); Behavioral: Auditory Consonant Trigrams Test; Behavioral: Controlled Oral Word Association Test; Behavioral: Hopkins Verbal Learning Test-Revised; Behavioral: The Center for Epidemiological Study-Depression; Behavioral: The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4; Other: Blood draw | Participants diagnosed with multiple myeloma in complete, partial or very good partial remission per standard International Myeloma Working Group Criteria will complete neurocognitive tests and structural and functional rsfMRI (brain MRIs). |
Sex: All, ages: 60 Years to 75 Years
Inclusion Criteria: * Diagnosed with multiple myeloma and in complete, partial or very good partial remission at enrollment as per standard International Myeloma Working Group Criteria * Scheduled to have high-dose chemotherapy and ASCT * Age 60 - 75 years at study entry * In the judgment of the consenting professional, fluent and able to communicate well enough in English to complete the study assessments and provide informed consent. * Patients who report that English is not their primary language will be asked the US Census English proficiency question "How well do you speak English" and the answer "very well" will be required Exclusion Criteria: * With signs and/or symptoms of central nervous system cancers (e.g., tumors, metastases, leptomeningial disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period * With current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report * As per patient report or as confirmed by the medical record, if the patient is taking anti-depression or anti-anxiety medication, < 2 months on these medications or a change in the prescribed dose in the past 2 months * With history of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report * With a history of another cancer, except for non-melanoma skin cancer, as per medical records or patient report * With current substance abuse and/or history of substance abuse, as per medical records or patient report * With evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report * With contraindications to MRI examinations as per standard screening guidelines used in the Department of Radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)
| Facility | City | Country | Status |
|---|---|---|---|
| Rutgers University - Data Analysis | New Brunswick, New Jersey | United States | |
| Memorial Sloan Kettering Cancer Center | New York, New York | United States |