Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation
1 other identifier
interventional
18
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-myeloma
Started Mar 2018
Longer than P75 for not_applicable multiple-myeloma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2018
CompletedFirst Submitted
Initial submission to the registry
April 11, 2018
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2024
CompletedMarch 8, 2024
March 1, 2024
5.9 years
April 11, 2018
March 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
rsfMRI + Neurocognitive Tests
EXPERIMENTALParticipants 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).
Interventions
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.
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.
Evaluates auditory attention and working memory
Assesses selective auditory attention
Assesses visual scanning, graphomotor speed, and setshifting
Assesses attention and susceptibility to interference
A timed test of verbal fluency.
The HVLT-R is a test of verbal learning and recall.
assesses perceived depression
A 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue
Blood samples will be collected at each time point (pre-ASCT; 3-4 months and post-ASCT) to assess serum levels of inflammatory cytokines.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rutgers University - Data Analysis
New Brunswick, New Jersey, 08903, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denise Correa, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2018
First Posted
April 26, 2018
Study Start
March 27, 2018
Primary Completion
March 6, 2024
Study Completion
March 6, 2024
Last Updated
March 8, 2024
Record last verified: 2024-03