2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy
brief summary
This study will assess whether adding one of the newest multiple myeloma therapies, daratumumab, into the Total Therapy approach helps patients live longer with fewer side effects
detailed description
Past studies conducted at the Myeloma Institute and at other institutions have shown that many patients with high-risk disease (as determined by gene array studies - studies that look at specific genes using special equipment) tend to have shorter remissions (disappearance of signs and symptoms of myeloma) and do not survive as long as participants with low-risk myeloma. The Total Therapy approach to treatment carried out at the Myeloma Institute where multiple chemotherapy agents are given as induction followed by a stem cell transplant, post-transplant consolidation, and maintenance therapy has proven to be the best available treatment strategy. However, the availability of new treatments that work in different ways offers the possibility of improving the effectiveness of Total Therapy treatment while potentially reducing the number of side effects patients' experience. Daratumumab is a human monoclonal antibody or protein drug. It recognizes a specific protein, CD38, which is found at high levels on multiple myeloma cells. An antibody is something that finds and kills foreign objects in your body, in this case, myeloma cells. The other drugs that will be used in the study treatment regimen include carfilzomib or bortezomib, thalidomide, lenalidomide, dexamethasone, cisplatin, adriamycin, cyclophosphamide, etoposide, lenalidomide and dexamethasone.
official title
2015-12: A Phase II Study Exploring the Use of Early and Late Consolidation/Maintenance With Anti-CD38 (Protein) Monoclonal Antibody to Improve Progression Free Survival in Patients With Newly Diagnosed Multiple Myeloma