A Study to Identify Barriers to Cellular Therapies for People With Plasma Cell Disorders
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
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:
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:
|
| 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:
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:
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:
|
| 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 |
Outcome Measures
Primary Outcome Measures
- Rates of referral [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Patient
-
Diagnosis of Multiple Myeloma after January 1, 2017.
-
Karnofsky Performance Status > 70%
-
≥ 2 lines of prior therapy
-
Started new line of therapy for RRMM within the last 12 months prior to registration
-
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 have already been referred will not be included.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 2 | Memorial Sloan Kettering Monmouth | Middletown | New Jersey | United States | 07748 |
| 3 | Memorial Sloan Kettering Bergen | Montvale | New Jersey | United States | 07645 |
| 4 | Memorial Sloan Kettering Commack | Commack | New York | United States | 11725 |
| 5 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 6 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 7 | Memorial Sloan Kettering Nassau | Uniondale | New York | United States | 11553 |
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
Investigators
- Principal Investigator: Heather Landau, MD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 23-166