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
1 other identifier
observational
49
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2023
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 3, 2023
CompletedFirst Submitted
Initial submission to the registry
November 6, 2023
CompletedFirst Posted
Study publicly available on registry
November 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 3, 2029
February 19, 2026
February 1, 2026
5.5 years
November 6, 2023
February 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (5)
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
Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-rated 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.
The Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress
The FACT-BMT Version 4.0 is a 37 item self-report questionnaire that measures the effect of cancer on Quality of Life domains
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
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patient
- Active CNS disease
- Patients who already have a definitive plan are to be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Hartford Healthcare Alliance
Hartford, Connecticut, 06102, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Landau, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2023
First Posted
November 13, 2023
Study Start
November 3, 2023
Primary Completion (Estimated)
May 3, 2029
Study Completion (Estimated)
May 3, 2029
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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.