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

NCT03508765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

Interventions

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.

DIAGNOSTIC_TEST

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

BEHAVIORAL

Brief Test of Attention

Assesses selective auditory attention

BEHAVIORAL

Trail Making Test (Parts A & B)

Assesses visual scanning, graphomotor speed, and setshifting

BEHAVIORAL

Auditory Consonant Trigrams Test

Assesses attention and susceptibility to interference

BEHAVIORAL

Controlled Oral Word Association Test

A timed test of verbal fluency.

BEHAVIORAL

Hopkins Verbal Learning Test-Revised

The HVLT-R is a test of verbal learning and recall.

BEHAVIORAL

The Center for Epidemiological Study-Depression

assesses perceived depression

BEHAVIORAL

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.

Sponsors & Collaborators

Principal Investigators

  • Denise Correa, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-27
Primary Completion
2024-03-06
Completion
2024-03-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03508765 on ClinicalTrials.gov