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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Enrolling

Conditions

Multiple Myeloma

Treatments

Behavioral: FACT-BMT
Behavioral: Duke-UNC Functional Social Support Questionnaire
Behavioral: Distress Thermometer
Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM
Behavioral: Psychosocial Assessments of Candidates for Transplantation
Behavioral: Hospital Anxiety and Depression Scale

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

400 participants in 5 patient groups

Participant Cohort 1
Description:
Relapse/refractory multiple myeloma/RRMM patients less than 70 years of age.
Treatment:
Behavioral: Hospital Anxiety and Depression Scale
Behavioral: FACT-BMT
Behavioral: Psychosocial Assessments of Candidates for Transplantation
Behavioral: Duke-UNC Functional Social Support Questionnaire
Behavioral: Distress Thermometer
Participant Cohort 2
Description:
Relapse/refractory multiple myeloma/RRMM patients 70 years of age or greater
Treatment:
Behavioral: Hospital Anxiety and Depression Scale
Behavioral: FACT-BMT
Behavioral: Psychosocial Assessments of Candidates for Transplantation
Behavioral: Duke-UNC Functional Social Support Questionnaire
Behavioral: Distress Thermometer
Physician Group 1: Primary Myeloma Therapy
Description:
Physicians in this group refer for cellular therapy but do not perform the infusions.
Treatment:
Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM
Physician Group 2: CAR Enabled
Description:
These physicians can order and infuse CAR T cells but not stem cells.
Treatment:
Other: Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM
Physician Group 3: HCT and CAR Enabled
Description:
These physicians can order and infuse stem cells and CAR T cells

Trial contacts and locations

7

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Central trial contact

Carlyn Tan, MD; Heather Landau, MD

Data sourced from clinicaltrials.gov

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