Study on Treatment Approach for Newly Diagnosed Multiple Myeloma in Transplant-Eligible Patients
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT07624513
This clinical trial is exploring the best treatment strategy for patients with newly diagnosed multiple myeloma who are eligible for a stem cell transplant. The study involves initial treatment with specific drugs, followed by additional therapy based on the patient's risk profile and response to treatment.
Patient Parameters
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Program Overview
The aim of this study is to find the most effective treatment plan for patients with newly diagnosed multiple myeloma who can undergo a stem cell transplant. The study will start with an initial treatment phase using the drugs isatuximab, iberdomide, bortezomib, and dexamethasone. After this, patients will receive further treatment tailored to their specific cancer risk and how well they responded to the initial treatment. The study includes various procedures such as eligibility screening, regular clinic visits, blood and bone marrow tests, and follow-up appointments. Approximately 720 participants are expected to join this study.
Description
This Phase III study is designed to evaluate different treatment strategies for people with multiple myeloma who are eligible for a stem cell transplant. Initially, all participants will receive a combination of drugs (isatuximab, iberdomide, bortezomib, and dexamethasone) for eight cycles. After this, patients will be grouped based on their cancer risk and response to the initial treatment. Those with standard-risk disease and no detectable cancer cells will continue with maintenance treatment using isatuximab and iberdomide. Patients with high-risk cancer or detectable cancer cells after initial treatment will receive either high-dose melphalan followed by a stem cell transplant or additional drug therapy. The study involves various tests and procedures, including blood and urine tests, scans, and bone marrow samples. The drugs used in this study are approved for treating multiple myeloma, and the study is supported by pharmaceutical companies providing the drugs free of charge.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with newly diagnosed multiple myeloma (NDMM) with specific criteria.
- Aged between 18 and 75 years old.
- Eligible for a stem cell transplant and willing to follow the study's treatment plan.
- Undergo specific tests to determine cancer risk and response to treatment.
- Have measurable disease based on specific medical tests.
- Meet certain health criteria, including blood counts and organ function.
- Able to complete quality of life assessments.
- Agree to use contraception during and after the study if sexually active.
- Willing to follow study procedures and not donate blood or sperm during and after the study.
Exclusion Criteria
- Have received prior therapy for multiple myeloma, except for specific cases.
- Known intolerance to steroid therapy.
- Cancer involvement in the central nervous system.
- History of certain neurological conditions or severe nerve damage.
- History of other cancers unless disease-free for at least 3 years, with some exceptions.
- Medical or psychiatric conditions that pose a risk to participation.
- Uncontrolled heart conditions or other serious health issues.
- Pregnant or breastfeeding women.
- Positive for certain infections like HIV or hepatitis.
- History of tuberculosis or systemic fungal disease.
- Active infection requiring treatment.
- Lack of specific cancer cell identification by required tests.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Beth Israel Deaconess Medical Center (BIDMC) | 02115 | Boston | Massachusetts |
| Brigham and Women's Hospital | 02115 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02115 | Boston | Massachusetts |
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