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

Study Overview
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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.

Official Title
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Prospective Multi-Center Study to Identify Barriers to Cellular Therapies in Patients With Plasma Cell Disorders PROACT PCD

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM
* Behavioral: Hospital Anxiety and Depression Scale
* Behavioral: Duke-UNC Functional Social Support Questionnaire
* Behavioral: Distress Thermometer
* Behavioral: FACT-BMT
* Behavioral: Psychosocial Assessments of Candidates for Transplantation


Participation Criteria
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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 Started new line of therapy for RRMM within the last 12 months prior to registration 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 have already been referred will not be included.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participant Cohort 1<br>Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age. | Behavioral: Hospital Anxiety and Depression Scale<br>* Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-rated questionnaire<br>* Other names: HADS;Behavioral: Duke-UNC Functional Social Support Questionnaire<br>* 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.<br>Behavioral: Distress Thermometer<br>* The Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress<br>* Other names: DT;Behavioral: FACT-BMT<br>* The FACT-BMT Version 4.0 is a 37 item self-report questionnaire that measures the effect of cancer on Quality of Life domains<br>Behavioral: Psychosocial Assessments of Candidates for Transplantation<br>* 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<br>* Other names: PACT;|
| Participant Cohort 2<br>Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater | Behavioral: Hospital Anxiety and Depression Scale<br>* Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-rated questionnaire<br>* Other names: HADS;Behavioral: Duke-UNC Functional Social Support Questionnaire<br>* 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.<br>Behavioral: Distress Thermometer<br>* The Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress<br>* Other names: DT;Behavioral: FACT-BMT<br>* The FACT-BMT Version 4.0 is a 37 item self-report questionnaire that measures the effect of cancer on Quality of Life domains<br>Behavioral: Psychosocial Assessments of Candidates for Transplantation<br>* 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<br>* Other names: PACT;|
| Physician Group 1: Primary Myeloma Therapy<br>Physicians in this group refer for cellular therapy but do not perform the infusions. | Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM<br>* 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.<br>|
| Physician Group 2: CAR Enabled<br>These physicians can order and infuse CAR T cells but not stem cells. | Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM<br>* 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.<br>|
| Physician Group 3: HCT and CAR Enabled<br>These physicians can order and infuse stem cells and CAR T cells | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of referral | To prospectively estimate the rates of referral and utilization of salvage autologous hematopoietic cell transplantation (HCT) and B cell maturation antigen (BCMA) Targeted Chimeric Antigen Receptor (CAR) autologous T cell therapies among patients with RRMM. | Up to 76 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCT, BCMA CAR T-cell therapy, Memorial Sloan Kettering Cancer Center, 23-166, Multiple Myeloma