The criteria for this mulitple myeloma study are listed below:
- Newly diagnosed multiple myeloma
- Medically less vigorous (frail) population
- Patients not fit for bone marrow transplant due to age or other medical condition
- Non chemo medication (daratumumab – a Monoclonal Antibody) in combination with low dose chemo
The purpose of this study is to compare daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of extent of disease remission in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant.
All the eligible participants will be randomly assigned to receive either daratumumab in combination with lenalidomide and dexamethasone (DRd) or lenalidomide and dexamethasone (Rd).
Daratumumab (Darzalex) was the first monoclonal antibody marketed for the treatment of patients with multiple myeloma who have received at least 3 previous lines of drug therapy. Daratumumab targets CD38, a protein expressed on the surface of multiple myeloma cells. Daratumumab is an investigational drug in newly diagnosed multiple myeloma patients.
What is Multilple Myeloma?
Cancer begins when the body's cells start to grow out of control. Cells in nearly any part of the body can become cancerous, and spread to other areas of the body. Multiple myeloma is a cancer formed by malignant plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system.
The immune system is composed of several types of cells that work together to fight infections and other diseases. Lymphocytes (lymph cells) are the main cell type of the immune system. The major types of lymphocytes are T cells and B cells.
When B cells respond to an infection, they mature and change into plasma cells. Plasma cells make the antibodies (also called immunoglobulins) that help the body attack and kill germs. Lymphocytes are in many areas of the body, such as lymph nodes, the bone marrow, the intestines, and the bloodstream. Plasma cells, however, are mainly found in the bone marrow. Bone marrow is the soft tissue inside some hollow bones. In addition to plasma cells, normal bone marrow has cells that make the different normal blood cells.
When plasma cells become cancerous and grow out of control, they can produce a tumor called a plasmacytoma. These tumors generally develop in a bone, but they are also rarely found in other tissues. If someone has only a single plasma cell tumor, the disease is called an isolated (or solitary) plasmacytoma. If someone has more than one plasmacytoma, they have multiple myeloma.
Source: American Cancer Society
For more information about the multiple myeloma study, contact:
Study PI: David Drew, MD, 954-267-7742
Study coordinator: Mariana, 954-267-7792
To learn more about The Michael and Dianne Bienes Comprehensive Cancer and our Clinical Research Studies, visit HolyCrossCancer.com.