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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Multiple Myeloma

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

Study type: Observational

Funder types: Other

Identifiers

NCT06126341

23-166

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 design

400 participants in 5 patient groups

Participant Cohort 1

Description:

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

Treatment:

Behavioral: Hospital Anxiety and Depression Scale

Behavioral: Psychosocial Assessments of Candidates for Transplantation

Behavioral: Distress Thermometer

Behavioral: Duke-UNC Functional Social Support Questionnaire

Behavioral: FACT-BMT

Participant Cohort 2

Description:

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

Treatment:

Behavioral: Hospital Anxiety and Depression Scale

Behavioral: Psychosocial Assessments of Candidates for Transplantation

Behavioral: Distress Thermometer

Behavioral: Duke-UNC Functional Social Support Questionnaire

Behavioral: FACT-BMT

Physician Group 1: Primary Myeloma Therapy

Description:

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

Treatment:

Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM

Physician Group 2: CAR Enabled

Description:

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

Treatment:

Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM

Physician Group 3: HCT and CAR Enabled

Description:

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