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

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ClinicalTrials.gov Identifier: NCT03508765
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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 and 12 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 12 months post-ASCT) to assess serum levels of inflammatory cytokines.




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 12 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 12 months following chemotherapy and ASCT ]


Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508765


Contacts
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Contact: Denise Correa, PhD 212-610-0491 corread@mskcc.org
Contact: Behroze Vachha, MD, PhD 212-639-2706 vachhab@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Denise Correa, PhD    212-610-0491    corread@mskcc.org   
Principal Investigator: Denise Correa, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Denise Correa, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03508765     History of Changes
Other Study ID Numbers: 18-154
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
ASCT
Memorial Sloan Kettering Cancer Center
18-154

Additional relevant MeSH terms:
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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