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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06126341
Other study ID # 23-166
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 3, 2023
Est. completion date May 3, 2029

Study information

Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact Heather Landau, MD
Phone 646-608-3740
Email ABMTTrials@mskcc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date May 3, 2029
Est. primary completion date May 3, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack Commack New York
United States Memorial Sloan Kettering Westchester Harrison New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rates of referral 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. Up to 76 months
See also
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Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
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Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1