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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: 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; Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Healthcare Alliance
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK). If the investigator is a member of the treatment team, s/he will screen their patient's medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential participants contacted by their treating physician will be referred to the investigator/research staff of the study. The principal investigator may also screen the medical records of patients with whom they do not have a treatment relationship for the limited purpose of identifying patients who would be eligible to enroll in the study and to record appropriate contact information in order to approach these patients regarding the possibility of enrolling in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participant Cohort 1; Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.	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; Other Names: HADS; 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; Other Names: DT; 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; Other Names: PACT
Participant Cohort 2; Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater	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; Other Names: HADS; 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; Other Names: DT; 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; Other Names: PACT
Physician Group 1: Primary Myeloma Therapy; 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; 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.	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.
Physician Group 3: HCT and CAR Enabled; These physicians can order and infuse stem cells and CAR T cells

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Heather Landau, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Estimated): May 3, 2029
• Study Completion (Estimated): May 3, 2029

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 6, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; Memorial Sloan Kettering Cancer Center; HCT; BCMA CAR T-cell therapy; 23-166
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Surgical Procedures, Operative; Transplantation; 4-amino-4'-hydroxylaminodiphenylsulfone
• Other Study ID Numbers: 23-166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No