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

Memorial Sloan Kettering Cancer Center2 sites in 1 country18 target enrollmentMarch 27, 2018

ConditionsMultiple Myeloma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 18
Locations: 2
Primary Endpoint: Changes in regional brain volume and functional connectivity when baseline and follow-up MRIs are compared.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 27, 2018

End Date

March 6, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

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

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