Clinical trial NCT06126341: A Study to Identify Barriers to Cellular Therapies for People With Plasma Cell Disorders
Official title: Prospective Multi-Center Study to Identify Barriers to Cellular Therapies in Patients With Plasma Cell Disorders PROACT PCD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
BCMA CAR T-cell therapy
HCT
Memorial Sloan Kettering Cancer Center
23-166
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: Rates of referral
timeFrame: Up to 76 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Heather Landau, MD
role: PRINCIPAL_INVESTIGATOR
References: