Trial Title:
A Study to Identify Barriers to Cellular Therapies for People With Plasma Cell Disorders
NCT ID:
NCT06126341
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Conditions: Keywords:
Multiple Myeloma
BCMA CAR T-cell therapy
HCT
Memorial Sloan Kettering Cancer Center
23-166
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Lecture on the role of cellular therapies in relapse/refractory multiple myeloma/RRMM
Description:
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.
Arm group label:
Physician Group 1: Primary Myeloma Therapy
Arm group label:
Physician Group 2: CAR Enabled
Intervention type:
Behavioral
Intervention name:
Hospital Anxiety and Depression Scale
Description:
Depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale
(HADS), a 14-item self-rated questionnaire
Arm group label:
Participant Cohort 1
Arm group label:
Participant Cohort 2
Other name:
HADS
Intervention type:
Behavioral
Intervention name:
Duke-UNC Functional Social Support Questionnaire
Description:
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.
Arm group label:
Participant Cohort 1
Arm group label:
Participant Cohort 2
Intervention type:
Behavioral
Intervention name:
Distress Thermometer
Description:
The Distress Thermometer is a single-item visual analog scale used to screen cancer
patients for the presence of psychological distress
Arm group label:
Participant Cohort 1
Arm group label:
Participant Cohort 2
Other name:
DT
Intervention type:
Behavioral
Intervention name:
FACT-BMT
Description:
The FACT-BMT Version 4.0 is a 37 item self-report questionnaire that measures the effect
of cancer on Quality of Life domains
Arm group label:
Participant Cohort 1
Arm group label:
Participant Cohort 2
Intervention type:
Behavioral
Intervention name:
Psychosocial Assessments of Candidates for Transplantation
Description:
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
Arm group label:
Participant Cohort 1
Arm group label:
Participant Cohort 2
Other name:
PACT
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Landau, MD
Phone:
212-639-8808
Facility:
Name:
Memorial Sloan Kettering Monmouth
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Landau, MD
Phone:
212-639-8808
Facility:
Name:
Memorial Sloan Kettering Bergen
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Landau, MD
Phone:
212-639-8808
Facility:
Name:
Memorial Sloan Kettering Commack
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Landau, MD
Phone:
212-639-8808
Facility:
Name:
Memorial Sloan Kettering Westchester
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Landau, MD
Phone:
212-639-8808
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Landau, MD
Phone:
646-608-3740
Facility:
Name:
Memorial Sloan Kettering Nassau
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Landau, MD
Phone:
212-639-8808
Start date:
November 3, 2023
Completion date:
May 3, 2029
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06126341
http://www.mskcc.org
