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

NCT03508765 — Not applicable, Completed, 18 participants, Memorial Sloan Kettering Cancer Center

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RegistryNCT03508765
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, diagnostic
Enrollment18 (Actual)
SponsorMemorial Sloan Kettering Cancer Center (Other)
ConditionsMultiple Myeloma
InterventionsStructural Image, Functional Image, Digit Span subtest, Brief Test of Attention, Trail Making Test (Parts A & B), Auditory Consonant Trigrams Test, Controlled Oral Word Association Test, Hopkins Verbal Learning Test-Revised, The Center for Epidemiological Study-Depression, The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4, Blood draw (Diagnostic test, behavioral, other)
Datesstart 2018-03-27, primary completion 2024-03-06, completion 2024-03-06, first posted 2018-04-26, last updated 2024-03-08
Locations2 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Multiple Myeloma All trials of Structural Image All trials of Functional Image

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
rsfMRI + Neurocognitive TestsExperimentalDiagnostic Test: Structural Image; Diagnostic Test: Functional Image; Behavioral: Digit Span subtest; Behavioral: Brief Test of Attention; Behavioral: Trail Making Test (Parts A & B); Behavioral: Auditory Consonant Trigrams Test; Behavioral: Controlled Oral Word Association Test; Behavioral: Hopkins Verbal Learning Test-Revised; Behavioral: The Center for Epidemiological Study-Depression; Behavioral: The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4; Other: Blood drawParticipants 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).
  • Structural Image (Diagnostic test), also known as Brain MRI: 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 (Diagnostic test), also known as rsfMRI: 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.
  • Digit Span subtest (Behavioral), also known as WAIS-IV: Evaluates auditory attention and working memory
  • Brief Test of Attention (Behavioral), also known as BTA: Assesses selective auditory attention
  • Trail Making Test (Parts A & B) (Behavioral): Assesses visual scanning, graphomotor speed, and setshifting
  • Auditory Consonant Trigrams Test (Behavioral): Assesses attention and susceptibility to interference
  • Controlled Oral Word Association Test (Behavioral), also known as COWAT: A timed test of verbal fluency.
  • Hopkins Verbal Learning Test-Revised (Behavioral), also known as HVLT-R: The HVLT-R is a test of verbal learning and recall.
  • The Center for Epidemiological Study-Depression (Behavioral), also known as CES-D: assesses perceived depression
  • The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4 (Behavioral), also known as FACIT-FS: A 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue
  • Blood draw (Other): Blood samples will be collected at each time point (pre-ASCT; 3-4 months and post-ASCT) to assess serum levels of inflammatory cytokines.

+Outcome measures

Primary outcomes

  • 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]

+Eligibility

Sex: All, ages: 60 Years to 75 Years

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)

+Locations (2)

FacilityCityCountryStatus
Rutgers University - Data AnalysisNew Brunswick, New JerseyUnited States
Memorial Sloan Kettering Cancer CenterNew York, New YorkUnited States

+Investigators