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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508765
• Other study ID #: 18-154
• Status: Completed
• Phase: N/A
• Start date: March 27, 2018
• Est. completion date: March 6, 2024

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 6, 2024
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.
• 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
• Brief Test of Attention
Assesses selective auditory attention
• Trail Making Test (Parts A & B)
Assesses visual scanning, graphomotor speed, and setshifting
• Auditory Consonant Trigrams Test
Assesses attention and susceptibility to interference
• Controlled Oral Word Association Test
A timed test of verbal fluency.
• Hopkins Verbal Learning Test-Revised
The HVLT-R is a test of verbal learning and recall.
• The Center for Epidemiological Study-Depression
assesses perceived depression
• 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.

Locations

Country	Name	City	State
United States	Rutgers University - Data Analysis	New Brunswick	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in regional brain volume and functional connectivity when baseline and follow-up MRIs are compared.		up to 4 months following chemotherapy and ASCT

External Links

•   Memorial Sloan Kettering Cancer Center