Multiple Myeloma Clinical Trial
Official title:
B- PRISM (Precision Intervention Smoldering Myeloma): A Phase II Trial of Combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma
The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma. The names of the study drugs involved in this study are: - Daratumumab (also called Darzalex Faspro) - Bortezomib (also called Velcade) - Lenalidomide (also called Revlimid) - Dexamethasone
The purpose of this research study is to learn whether the combination of daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma. This combination of drugs are considered "investigational" which means it has not been approved in this combination for smoldering myeloma by the United States Food and Drug Administration. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits The names of the study drugs involved in this study are: - Daratumumab (also called Darzalex Faspro) - Bortezomib (also called Velcade) - Lenalidomide (also called Revlimid) - Dexamethasone Participants may be treated for up to 24 months and will be followed for up to 3 years. It is expected that about 30 people will take part in this research study. This research study is a Phase II clinical trial, which tests the effectiveness of an investigational drug(s). The investigational drugs used in this research study are daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone. "Investigational" means that the FDA (the U.S. Food and Drug Administration) has not approved the combination of daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone as a treatment regimen for the specific disease. ;
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