Multiple Myeloma
Conditions
Keywords
ASCT, Memorial Sloan Kettering Cancer Center, 18-154
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.
Interventions
DIAGNOSTIC_TESTStructural 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.
DIAGNOSTIC_TESTFunctional 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.
BEHAVIORALDigit Span subtest
Evaluates auditory attention and working memory
BEHAVIORALBrief Test of Attention
Assesses selective auditory attention
BEHAVIORALTrail Making Test (Parts A & B)
Assesses visual scanning, graphomotor speed, and setshifting
BEHAVIORALAuditory Consonant Trigrams Test
Assesses attention and susceptibility to interference
BEHAVIORALControlled Oral Word Association Test
A timed test of verbal fluency.
BEHAVIORALHopkins Verbal Learning Test-Revised
The HVLT-R is a test of verbal learning and recall.
BEHAVIORALThe Center for Epidemiological Study-Depression
assesses perceived depression
BEHAVIORALThe 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
OTHERBlood 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in regional brain volume and functional connectivity when baseline and follow-up MRIs are compared. | 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 | up to 4 months following chemotherapy and ASCT |
Countries
United States
Outcome results
None listed