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

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Structural Image
Functional Image
Digit Span subtest
Brief Test of Attention
Trail Making Test (Parts A & B)
Auditory Consonant Trigrams Test
Controlled Oral Word Association Test
Hopkins Verbal Learning Test-Revised
The Center for Epidemiological Study-Depression
The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4
Blood draw
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Myeloma focused on measuring ASCT, Memorial Sloan Kettering Cancer Center, 18-154

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Rutgers University - Data Analysis
  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rsfMRI + Neurocognitive Tests

Arm 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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 11, 2018
Last Updated
March 9, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03508765
Brief Title
Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation
Official Title
Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
ASCT, Memorial Sloan Kettering Cancer Center, 18-154

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rsfMRI + Neurocognitive Tests
Arm Type
Experimental
Arm 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).
Intervention Type
Diagnostic Test
Intervention Name(s)
Structural Image
Other Intervention Name(s)
Brain MRI
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Functional Image
Other Intervention Name(s)
rsfMRI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Digit Span subtest
Other Intervention Name(s)
WAIS-IV
Intervention Description
Evaluates auditory attention and working memory
Intervention Type
Behavioral
Intervention Name(s)
Brief Test of Attention
Other Intervention Name(s)
BTA
Intervention Description
Assesses selective auditory attention
Intervention Type
Behavioral
Intervention Name(s)
Trail Making Test (Parts A & B)
Intervention Description
Assesses visual scanning, graphomotor speed, and setshifting
Intervention Type
Behavioral
Intervention Name(s)
Auditory Consonant Trigrams Test
Intervention Description
Assesses attention and susceptibility to interference
Intervention Type
Behavioral
Intervention Name(s)
Controlled Oral Word Association Test
Other Intervention Name(s)
COWAT
Intervention Description
A timed test of verbal fluency.
Intervention Type
Behavioral
Intervention Name(s)
Hopkins Verbal Learning Test-Revised
Other Intervention Name(s)
HVLT-R
Intervention Description
The HVLT-R is a test of verbal learning and recall.
Intervention Type
Behavioral
Intervention Name(s)
The Center for Epidemiological Study-Depression
Other Intervention Name(s)
CES-D
Intervention Description
assesses perceived depression
Intervention Type
Behavioral
Intervention Name(s)
The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4
Other Intervention Name(s)
FACIT-FS
Intervention Description
A 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue
Intervention Type
Other
Intervention Name(s)
Blood draw
Intervention Description
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 Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Correa, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University - Data Analysis
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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