Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation

Memorial Sloan Kettering Cancer Center (MSK)

Status

Completed

Conditions

Multiple Myeloma

Treatments

Other: Blood draw

Behavioral: Brief Test of Attention

Behavioral: Trail Making Test (Parts A & B)

Behavioral: The Center for Epidemiological Study-Depression

Behavioral: Hopkins Verbal Learning Test-Revised

Behavioral: The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4

Diagnostic Test: Functional Image

Behavioral: Digit Span subtest

Behavioral: Controlled Oral Word Association Test

Diagnostic Test: Structural Image

Behavioral: Auditory Consonant Trigrams Test

Study type

Interventional

Funder types

Other

Identifiers

NCT03508765

18-154

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

60 to 75 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

rsfMRI + Neurocognitive Tests

Experimental group

Description:

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).

Treatment: