Clinical trial · Interventional
Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation
NCT03508765CI-TRIAL-00074864completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Auditory Consonant Trigrams Test | Behavioral | — | UNRESOLVED |
| Blood draw | Other | — | UNRESOLVED |
| Brief Test of Attention | Behavioral | — | UNRESOLVED |
| Controlled Oral Word Association Test | Behavioral | — | UNRESOLVED |
| Digit Span subtest | Behavioral | — | UNRESOLVED |
| Functional Image | Diagnostic Test | — | UNRESOLVED |
| Hopkins Verbal Learning Test-Revised | Behavioral | — | UNRESOLVED |
| Structural Image | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- rsfMRI + Neurocognitive Tests
- description
- 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).
- interventionNames
- 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
Primary outcomes (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.