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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06126341
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Heather Landau, MD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma
Study Website:	View Trial Website

Arms & Interventions

Arms

: Participant Cohort 1

Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.

: Participant Cohort 2

Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater

: Physician Group 1: Primary Myeloma Therapy

Physicians in this group refer for cellular therapy but do not perform the infusions.

: Physician Group 2: CAR Enabled

These physicians can order and infuse CAR T cells but not stem cells.

: Physician Group 3: HCT and CAR Enabled

These physicians can order and infuse stem cells and CAR T cells

Interventions

Other: - 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.

Behavioral: - 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

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.

Behavioral: - Distress Thermometer

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

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

Site Contact

Heather Landau, MD

ABMTTrials@mskcc.org

212-639-8808

Memorial Sloan Kettering Monmouth, Middletown, New Jersey

Status