A Study to Identify Barriers to Cellular Therapies for People With Plasma Cell Disorders

NCT ID: NCT06126341

Last Updated: 2025-10-23

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-03

Study Completion Date

2029-05-03

Brief Summary

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This is an observational study that will include both participants with relapsed/refractory Multiple Myeloma and their doctors. The purpose of this study is to gather information about the use of hematopoietic cell transplantation/HCT and B-cell maturation antigen /BCMS targeted chimeric antigen receptor/CAR autologous T-cell therapy.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

The Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress

FACT-BMT

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

The Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress

FACT-BMT

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Distress Thermometer

The Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Other Intervention Names

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HADS DT PACT

Eligibility Criteria

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Inclusion Criteria

Patient

* 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

Patient

* Active CNS disease
* Patients who already have a definitive plan are to be excluded
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status NOT_YET_RECRUITING

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Heather Landau, MD

Role: CONTACT

646-608-3740

Carlyn Tan, MD

Role: CONTACT

646-608-3778

Facility Contacts

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Mark Dailey, MD

Role: primary

860-249-6291

Heather Landau, MD

Role: primary

212-639-8808

Heather Landau, MD

Role: primary

212-639-8808

Heather Landau, MD

Role: primary

212-639-8808

Heather Landau, MD

Role: primary

212-639-8808

Heather Landau, MD

Role: primary

212-639-8808

Heather Landau, MD

Role: primary

646-608-3740

Heather Landau, MD

Role: primary

212-639-8808

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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23-166

Identifier Type: -

Identifier Source: org_study_id

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