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

Recruiting

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

• Registration Number: NCT06126341
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-11-03
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-06
• Study First Posted: 2023-11-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2029-05-03
• Study Completion: 2029-05-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participant Cohort 1	Duke-UNC Functional Social Support Questionnaire	Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
Participant Cohort 2	Psychosocial Assessments of Candidates for Transplantation	Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
Participant Cohort 1	Hospital Anxiety and Depression Scale	Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
Participant Cohort 2	FACT-BMT	Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
Participant Cohort 1	FACT-BMT	Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
Participant Cohort 2	Hospital Anxiety and Depression Scale	Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
Participant Cohort 2	Duke-UNC Functional Social Support Questionnaire	Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
Physician Group 1: Primary Myeloma Therapy	Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM	Physicians in this group refer for cellular therapy but do not perform the infusions.
Participant Cohort 1	Psychosocial Assessments of Candidates for Transplantation	Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
Participant Cohort 2	Distress Thermometer	Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
Participant Cohort 1	Distress Thermometer	Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
Physician Group 2: CAR Enabled	Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM	These physicians can order and infuse CAR T cells but not stem cells.

Primary Outcome Measures

Name	Time	Method
Rates of referral	Up to 76 months	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.

Trial Locations

Locations (7)

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