Multiple MyelomaNCT03508765
Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation
A study testing Structural Image, Functional Image and Digit Span subtest in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Structural Image, Functional Image and Digit Span subtest
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Mar 2018to 6 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rutgers University - Data Analysis
New Brunswick, New Jersey, 08903
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
- Conditions
- Multiple Myeloma
- Being tested
- Structural Image, Functional Image, Digit Span subtest, Brief Test of Attention, Trail Making Test (Parts A & B)
- Keywords
- ASCT, Memorial Sloan Kettering Cancer Center, 18-154
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural ImageDiagnostic test
Also called 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 ImageDiagnostic test
Also called 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 subtestBehavioural
Also called WAIS-IV
Evaluates auditory attention and working memory
Brief Test of AttentionBehavioural
Also called BTA
Assesses selective auditory attention
Trail Making Test (Parts A & B)Behavioural
Assesses visual scanning, graphomotor speed, and setshifting
Auditory Consonant Trigrams TestBehavioural
Assesses attention and susceptibility to interference
Controlled Oral Word Association TestBehavioural
Also called COWAT
A timed test of verbal fluency.
Hopkins Verbal Learning Test-RevisedBehavioural
Also called HVLT-R
The HVLT-R is a test of verbal learning and recall.
The Center for Epidemiological Study-DepressionBehavioural
Also called CES-D
assesses perceived depression
The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4Behavioural
Also called FACIT-FS
A 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue
Blood drawOther
Blood samples will be collected at each time point (pre-ASCT; 3-4 months and post-ASCT) to assess serum levels of inflammatory cytokines.
| Study group | Role | What they receive |
|---|---|---|
| rsfMRI + Neurocognitive Tests | Experimental | 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). Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 4 months following chemotherapy and ASCT
Changes in regional brain volume and functional connectivity when baseline and follow-up MRIs are compared.
Measured: up to 4 months following chemotherapy and ASCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start27 Mar 2018
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denise Correa, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508765
- Sponsor's protocol ID
- 18-154
- Status last verified
- Mar 2024
- First submitted
- 11 Apr 2018
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03508765
- Acronym / sponsor ID
- 18-154
- Conditions
- Multiple Myeloma
- Keywords
- ASCT, Memorial Sloan Kettering Cancer Center, 18-154
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rsfMRI + Neurocognitive Tests | Experimental | 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 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). |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural ImageAlso: Brain MRIPatients 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 test | rsfMRI + Neurocognitive Tests |
| Functional ImageAlso: rsfMRIPatients 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 test | rsfMRI + Neurocognitive Tests |
| Digit Span subtestAlso: WAIS-IVEvaluates auditory attention and working memory | Behavioural | rsfMRI + Neurocognitive Tests |
| Brief Test of AttentionAlso: BTAAssesses selective auditory attention | Behavioural | rsfMRI + Neurocognitive Tests |
| Trail Making Test (Parts A & B)Assesses visual scanning, graphomotor speed, and setshifting | Behavioural | rsfMRI + Neurocognitive Tests |
| Auditory Consonant Trigrams TestAssesses attention and susceptibility to interference | Behavioural | rsfMRI + Neurocognitive Tests |
| Controlled Oral Word Association TestAlso: COWATA timed test of verbal fluency. | Behavioural | rsfMRI + Neurocognitive Tests |
| Hopkins Verbal Learning Test-RevisedAlso: HVLT-RThe HVLT-R is a test of verbal learning and recall. | Behavioural | rsfMRI + Neurocognitive Tests |
| The Center for Epidemiological Study-DepressionAlso: CES-Dassesses perceived depression | Behavioural | rsfMRI + Neurocognitive Tests |
| The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4Also: FACIT-FSA 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue | Behavioural | rsfMRI + Neurocognitive Tests |
| Blood drawBlood samples will be collected at each time point (pre-ASCT; 3-4 months and post-ASCT) to assess serum levels of inflammatory cytokines. | Other | rsfMRI + Neurocognitive Tests |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise Correa, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structural Image, Functional Image and Digit Span subtest in people with Multiple Myeloma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: up to 4 months following chemotherapy and ASCT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.