Study on CAR-PRISM: Precision Intervention for High-Risk Smoldering Myeloma
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT05767359
This clinical trial is testing a new treatment called ciltacabtagene autoleucel (cilta-cel) to see if it is safe and effective for people with high-risk smoldering myeloma. The study involves using special immune cells, along with chemotherapy, to target the disease.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new treatment called cilta-cel for people with high-risk smoldering multiple myeloma (SMM). Cilta-cel is a type of therapy that uses a person's own immune cells, called T cells, to fight cancer. The study will also use chemotherapy drugs, cyclophosphamide and fludarabine, to help prepare the body for the treatment. The U.S. FDA has approved cilta-cel for other types of multiple myeloma, but not specifically for smoldering myeloma. Participants will undergo various procedures, including blood tests, scans, and bone marrow biopsies, and will be followed for about 15 years. Approximately 20 people will participate in this Phase II clinical trial, which aims to test the treatment's safety and effectiveness.
Description
This Phase II study is designed to test the safety and effectiveness of cilta-cel in treating high-risk smoldering multiple myeloma (SMM). Cilta-cel is a therapy that uses a person's own T cells, which are part of the immune system, to target and fight cancer cells. Although cilta-cel is approved for other types of multiple myeloma, it is still being studied for smoldering myeloma. Participants will be screened for eligibility and will undergo various procedures, including blood tests, scans, and bone marrow biopsies. The study will last about 15 years, and around 20 people are expected to take part. Janssen Research & Development, LLC is providing the treatment and funding for this study.
Eligibility Criteria
Inclusion Criteria
- Must be over 18 years old.
- Have high-risk smoldering multiple myeloma (SMM) with specific criteria, such as certain levels of plasma cells in the bone marrow and other risk factors.
- No evidence of active multiple myeloma symptoms, such as high calcium levels, kidney problems, anemia, or bone lesions.
- Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Specific blood test results within normal ranges.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for one year after treatment.
- Men must agree to use a barrier method of contraception and not donate sperm during the study and for one year after treatment.
- Must provide informed consent to participate in the study.
Exclusion Criteria
- Have received prior treatment specifically for smoldering multiple myeloma.
- Have symptomatic multiple myeloma or evidence of active disease.
- Have other ongoing cancer treatments or have participated in other clinical trials for smoldering myeloma.
- Have serious medical or psychiatric conditions that could interfere with the study.
- Have been diagnosed or treated for another cancer within the last two years, except for certain skin cancers or low-risk prostate cancer.
- Have uncontrolled illnesses, such as heart failure or infections.
- Plan to father a child or become pregnant during the study or within one year after treatment.
- Have active viral infections, such as HIV, hepatitis B, or hepatitis C.
- Have allergies or intolerances to any study drugs.
- Have had certain treatments or vaccines within a specified time before the study.
- Have active central nervous system involvement or other specific health conditions that could affect participation.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.