A Study to Identify Barriers to Cellular Therapies for People With Plasma Cell Disorders
NCT ID: NCT06126341
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2023-11-03
2029-05-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participant Cohort 1
Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
Hospital Anxiety and Depression Scale
Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-rated questionnaire
Duke-UNC Functional Social Support Questionnaire
A 14-item, self-administered, multidimensional, functional social support questionnaire has been reduced to an 11 items to a brief and easy-to-complete two-scale, eight-item functional social support instrument.
Distress Thermometer
The Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress
FACT-BMT
The FACT-BMT Version 4.0 is a 37 item self-report questionnaire that measures the effect of cancer on Quality of Life domains
Psychosocial Assessments of Candidates for Transplantation
The PACT scale is a single page 10-item rating scale with high inter-rater reliability that has been used extensively in solid organ transplantation
Participant Cohort 2
Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
Hospital Anxiety and Depression Scale
Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-rated questionnaire
Duke-UNC Functional Social Support Questionnaire
A 14-item, self-administered, multidimensional, functional social support questionnaire has been reduced to an 11 items to a brief and easy-to-complete two-scale, eight-item functional social support instrument.
Distress Thermometer
The Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress
FACT-BMT
The FACT-BMT Version 4.0 is a 37 item self-report questionnaire that measures the effect of cancer on Quality of Life domains
Psychosocial Assessments of Candidates for Transplantation
The PACT scale is a single page 10-item rating scale with high inter-rater reliability that has been used extensively in solid organ transplantation
Physician Group 1: Primary Myeloma Therapy
Physicians in this group refer for cellular therapy but do not perform the infusions.
Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM
Physician investigators will review a lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM that discusses current information in regards to available cellular therapies in RRMM and a proposed treatment algorithm.
Physician Group 2: CAR Enabled
These physicians can order and infuse CAR T cells but not stem cells.
Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM
Physician investigators will review a lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM that discusses current information in regards to available cellular therapies in RRMM and a proposed treatment algorithm.
Physician Group 3: HCT and CAR Enabled
These physicians can order and infuse stem cells and CAR T cells
No interventions assigned to this group
Interventions
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Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM
Physician investigators will review a lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM that discusses current information in regards to available cellular therapies in RRMM and a proposed treatment algorithm.
Hospital Anxiety and Depression Scale
Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-rated questionnaire
Duke-UNC Functional Social Support Questionnaire
A 14-item, self-administered, multidimensional, functional social support questionnaire has been reduced to an 11 items to a brief and easy-to-complete two-scale, eight-item functional social support instrument.
Distress Thermometer
The Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress
FACT-BMT
The FACT-BMT Version 4.0 is a 37 item self-report questionnaire that measures the effect of cancer on Quality of Life domains
Psychosocial Assessments of Candidates for Transplantation
The PACT scale is a single page 10-item rating scale with high inter-rater reliability that has been used extensively in solid organ transplantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Multiple Myeloma after January 1, 2017.
* Karnofsky Performance Status \> 70%
* ≥ 2 lines of prior therapy
* Anticipated to start new a line of therapy for RRMM within the next 12 months
* Age 18-80 years of age.
* English or Spanish speaking.
* Willing to provide informed consent
* Willing to perform study procedures.
Physician Investigator
* Be a Co-Investigator
* Agree to comply with study procedures
Exclusion Criteria
* Active CNS disease
* Patients who already have a definitive plan are to be excluded
18 Years
80 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Heather Landau, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Hartford Healthcare Alliance
Hartford, Connecticut, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Mark Dailey, MD
Role: primary
Heather Landau, MD
Role: primary
Heather Landau, MD
Role: primary
Heather Landau, MD
Role: primary
Heather Landau, MD
Role: primary
Heather Landau, MD
Role: primary
Heather Landau, MD
Role: primary
Heather Landau, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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23-166
Identifier Type: -
Identifier Source: org_study_id
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