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OpenTrials
Completed

NCT Number: NCT03508765

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

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.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University - Data Analysis, New Brunswick, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Structural Image

Diagnostic Test

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.

Other names: Brain MRI

Functional Image

Diagnostic Test

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.

Other names: rsfMRI

Digit Span subtest

Behavioral

Evaluates auditory attention and working memory

Other names: WAIS-IV

Brief Test of Attention

Behavioral

Assesses selective auditory attention

Other names: BTA

Trail Making Test (Parts A & B)

Behavioral

Assesses visual scanning, graphomotor speed, and setshifting

Auditory Consonant Trigrams Test

Behavioral

Assesses attention and susceptibility to interference

Controlled Oral Word Association Test

Behavioral

A timed test of verbal fluency.

Other names: COWAT

Hopkins Verbal Learning Test-Revised

Behavioral

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

Other names: HVLT-R

The Center for Epidemiological Study-Depression

Behavioral

assesses perceived depression

Other names: CES-D

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

Behavioral

A 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue

Other names: FACIT-FS

Blood Draw

Other

Blood samples will be collected at each time point (pre-ASCT; 3-4 months and post-ASCT) to assess serum levels of inflammatory cytokines.

Primary outcomes

  1. 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

    Time frame: up to 4 months following chemotherapy and ASCT

  2. Changes in regional brain volume and functional connectivity when baseline and follow-up MRIs are compared.

    Time frame: up to 4 months following chemotherapy and ASCT

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2018
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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