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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Diagnostic test: Structural Image; Diagnostic test: Functional Image; Behavioral: Digit Span subtest; Behavioral: Brief Test of Attention; Behavioral: Trail Making Test (Parts A & B); Behavioral: Auditory Consonant Trigrams Test; Behavioral: Controlled Oral Word Association Test; Behavioral: Hopkins Verbal Learning Test-Revised; Behavioral: The Center for Epidemiological Study-Depression; Behavioral: The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4; Other: Blood draw

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers University - Data Analysis
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

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.; Other Names: Brain MRI; 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.; Other Names: rsfMRI; Behavioral: Digit Span subtest; Evaluates auditory attention and working memory; Other Names: WAIS-IV; Behavioral: Brief Test of Attention; Assesses selective auditory attention; Other Names: BTA; 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.; Other Names: COWAT; Behavioral: Hopkins Verbal Learning Test-Revised; The HVLT-R is a test of verbal learning and recall.; Other Names: HVLT-R; Behavioral: The Center for Epidemiological Study-Depression; assesses perceived depression; Other Names: CES-D; 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 Names: FACIT-FS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Changes in regional brain volume and functional connectivity when baseline and follow-up MRIs are compared.	up to 4 months following chemotherapy and ASCT

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Denise Correa, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2018
• Primary Completion (Actual): March 6, 2024
• Study Completion (Actual): March 6, 2024

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; ASCT; 18-154
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: 18-154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes