Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation
NCT ID: NCT03508765
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2018-03-27
2024-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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rsfMRI + Neurocognitive Tests
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).
Structural Image
Patients will undergo structural and functional (rsfMRI) brain MRIs (total time= \~15 minutes) at enrollment (prior to HD-Chemo/ASCT) and approximately 3-4 months after ASCT.
Functional Image
Patients will undergo structural and functional (rsfMRI) brain MRIs (total time= \~15 minutes) at enrollment (prior to HD-Chemo/ASCT) and approximately 3-4 months after ASCT.
Digit Span subtest
Evaluates auditory attention and working memory
Brief Test of Attention
Assesses selective auditory attention
Trail Making Test (Parts A & B)
Assesses visual scanning, graphomotor speed, and setshifting
Auditory Consonant Trigrams Test
Assesses attention and susceptibility to interference
Controlled Oral Word Association Test
A timed test of verbal fluency.
Hopkins Verbal Learning Test-Revised
The HVLT-R is a test of verbal learning and recall.
The Center for Epidemiological Study-Depression
assesses perceived depression
The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4
A 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue
Blood draw
Blood samples will be collected at each time point (pre-ASCT; 3-4 months and post-ASCT) to assess serum levels of inflammatory cytokines.
Interventions
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Structural Image
Patients will undergo structural and functional (rsfMRI) brain MRIs (total time= \~15 minutes) at enrollment (prior to HD-Chemo/ASCT) and approximately 3-4 months after ASCT.
Functional Image
Patients will undergo structural and functional (rsfMRI) brain MRIs (total time= \~15 minutes) at enrollment (prior to HD-Chemo/ASCT) and approximately 3-4 months after ASCT.
Digit Span subtest
Evaluates auditory attention and working memory
Brief Test of Attention
Assesses selective auditory attention
Trail Making Test (Parts A & B)
Assesses visual scanning, graphomotor speed, and setshifting
Auditory Consonant Trigrams Test
Assesses attention and susceptibility to interference
Controlled Oral Word Association Test
A timed test of verbal fluency.
Hopkins Verbal Learning Test-Revised
The HVLT-R is a test of verbal learning and recall.
The Center for Epidemiological Study-Depression
assesses perceived depression
The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4
A 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue
Blood draw
Blood samples will be collected at each time point (pre-ASCT; 3-4 months and post-ASCT) to assess serum levels of inflammatory cytokines.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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)
60 Years
75 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Denise Correa, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Rutgers University - Data Analysis
New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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18-154
Identifier Type: -
Identifier Source: org_study_id
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