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NCT Number: NCT06126341

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hartford Healthcare Alliance, Hartford, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

Hospital Anxiety and Depression Scale

Behavioral

Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-rated questionnaire

Other names: HADS

Duke-UNC Functional Social Support Questionnaire

Behavioral

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.

Distress Thermometer

Behavioral

The Distress Thermometer is a single-item visual analog scale used to screen cancer patients for the presence of psychological distress

Other names: DT

FACT-BMT

Behavioral

The FACT-BMT Version 4.0 is a 37 item self-report questionnaire that measures the effect of cancer on Quality of Life domains

Psychosocial Assessments of Candidates for Transplantation

Behavioral

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Nov 13, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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