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

• ClinicalTrials.gov Identifier: NCT03508765
• Recruitment Status: Active, not recruiting
• First Posted: April 26, 2018
• Last Update Posted: March 10, 2022
• Sponsor: Memorial Sloan Kettering Cancer Center
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Diagnostic 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 draw	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation
• Actual Study Start Date: March 27, 2018
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: March 2023

Arms and Interventions

Arm

Intervention/treatment

Experimental: rsfMRI + Neurocognitive Tests; Participants 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).

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.; Other Name: Brain MRI; Diagnostic Test: 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.; Other Name: rsfMRI; Behavioral: Digit Span subtest; Evaluates auditory attention and working memory; Other Name: WAIS-IV; Behavioral: Brief Test of Attention; Assesses selective auditory attention; Other Name: BTA; Behavioral: Trail Making Test (Parts A & B); Assesses visual scanning, graphomotor speed, and setshifting; Behavioral: Auditory Consonant Trigrams Test; Assesses attention and susceptibility to interference; Behavioral: Controlled Oral Word Association Test; A timed test of verbal fluency.; Other Name: COWAT; Behavioral: Hopkins Verbal Learning Test-Revised; The HVLT-R is a test of verbal learning and recall.; Other Name: HVLT-R; Behavioral: The Center for Epidemiological Study-Depression; assesses perceived depression; Other Name: CES-D; Behavioral: 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 Name: FACIT-FS; 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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 60 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, New Jersey

Rutgers University - Data Analysis

New Brunswick, New Jersey, United States, 08903

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Denise Correa, PhD; Memorial Sloan Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center 

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT03508765
• Other Study ID Numbers: 18-154
• First Posted: April 26, 2018
• Last Update Posted: March 10, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Memorial Sloan Kettering Cancer Center:

ASCT; Memorial Sloan Kettering Cancer Center; 18-154

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases