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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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06126341
Enrollment
49
Registered
2023-11-13
Start date
2023-11-03
Completion date
2029-05-03
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, BCMA CAR T-cell therapy, HCT, Memorial Sloan Kettering Cancer Center, 23-166

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.

Interventions

OTHERLecture 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.

BEHAVIORALHospital Anxiety and Depression Scale

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

BEHAVIORALDuke-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.

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

BEHAVIORALFACT-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

BEHAVIORALPsychosocial 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

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rates of referralUp to 76 monthsTo 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHeather Landau, MD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026