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Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

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NCT05561387
Age Any Age.
Sex Both
Phase Phase 3
Third Opinion Trial Synopsis
This research study is comparing different treatments for a type of cancer called multiple myeloma. The study is focused on patients who are not getting a certain type of treatment called a stem cell transplant and who are considered frail or not very healthy. The study is looking at different combinations of drugs to see which one works best to make the cancer shrink and stay under control. The drugs being studied are bortezomib, lenalidomide, dexamethasone, and daratumumab with hyaluronidase-fihj. These drugs work in different ways to stop the cancer from growing. The goal of the study is to find the best treatment for people with multiple myeloma who can't have a stem cell transplant.
Third Opinion AI Generated Synopsis

Trial Summary
This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.
from ClinicalTrials.gov

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