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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03508765
Other study ID # 18-154
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 27, 2018
Est. completion date March 6, 2024

Study information

Verified date March 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date March 6, 2024
Est. primary completion date March 6, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years to 75 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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.
Behavioral:
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
Other:
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.

Locations

Country Name City State
United States Rutgers University - Data Analysis New Brunswick New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in neurocognitive functions in older participants with Multiple Myeloma following high-dose (HD) chemotherapy and autologous stem cell transplantation (ASCT) assessed by initial and follow-up neurocognitive evaluation up to 4 months following chemotherapy and ASCT
Primary Changes in regional brain volume and functional connectivity when baseline and follow-up MRIs are compared. up to 4 months following chemotherapy and ASCT
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