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

February 17, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rates of referral
Time Frame: 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.
Up to 76 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather Landau, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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