Clinical trial NCT03508765: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: ASCT
Memorial Sloan Kettering Cancer Center
18-154
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-04-26
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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)

Primary outcomes:
measure: 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
timeFrame: up to 4 months following chemotherapy and ASCT
measure: Changes in regional brain volume and functional connectivity when baseline and follow-up MRIs are compared.
timeFrame: up to 4 months following chemotherapy and ASCT
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University - Data Analysis
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Denise Correa, PhD
role: PRINCIPAL_INVESTIGATOR
References: