This trial is evaluating whether Daratumumab will improve 1 primary outcome in patients with Multiple Myeloma. Measurement will happen over the course of 48 months.
This trial requires 50 total participants across 1 different treatment group
This trial involves a single treatment. Daratumumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
"The cause of MM is largely still unknown and remains a subject of controversy. This may be partly because there continues to be a lack of funds for cancer research throughout the world. However, a large proportion of studies do uncover biomarkers (cancer proteins) that can be used to help identify a risk of developing the disease. On a basic level, the risk of developing MM appears to be higher among those exposed to environmental contaminants, such as those emitted by traffic, or those who live in polluted cities. Exposure to sunlight or vitamin D deficiency enhances the risk of developing MM. At a higher level, it is shown that there may be certain genes that predispose individuals to development of the disease." - Anonymous Online Contributor
"In early MM, fever, abdominal pain, fatigue, and low-grade Bence Jones proteinuria are usually the first clinical symptoms. In contrast, in late MM, Bence Jones proteinuria is more commonly associated with anemia, but abdominal pain and painless jaundice are more common." - Anonymous Online Contributor
"One hundred and one myeloma patients received a therapy that had proven effectiveness in at least one study (a minimum of two studies were needed for a therapy to be considered common). The majority of common therapies to myeloma are associated with significant toxicity; most of these treatments are only rarely used by patients." - Anonymous Online Contributor
"In children, high-risk acute leukemia tends not to be curable. Allogeneic stem cell transplantations are not curative, but can improve survival in children with high-risk acute leukemia. However, curative treatment is possible in children with multiple myeloma." - Anonymous Online Contributor
"Multiple myeloma is a cancer of plasma cells. It is a type of lymphoproliferative disease. This disease can also invade structures in the brain and spinal cord, which cause symptoms. It has a poor survival rate." - Anonymous Online Contributor
"In the United States, more than 4,000 patients develop MM in 2008; most of these were in men aged 50–69 years with a newly diagnosed MM. Patients with MM in the United States have different characteristics and staging compared with patients in Europe, Australia and New Zealand (USA)." - Anonymous Online Contributor
"Daratumumab demonstrated an improvement in progression-free survival compared to lenalidomide after three or more months of lenalidomide, suggesting improvements in disease dynamics of multiple myeloma." - Anonymous Online Contributor
"The last 30 years have resulted in the most complete understanding of the [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) genome sequence. However, more work still needs to be done to fully understand the mechanisms of cancer, how the cancer begins, and how it progresses. Genetic predisposition to myeloma is not recognized as a risk factor for multiple myeloma. Further research in this area may help to understand what triggers cancer and the mechanisms involved in multiple myeloma." - Anonymous Online Contributor
"The only registered clinical trial involving daratumumab was a phase IIa trial in combination with prednisone and bisphosphonates, in a large population of relapsed multiple myeloma patients, that did not specify response by imaging. However, several authors have indicated that the results of this trial are being interpreted in a very favorable way. As this study was registered before completion, a number of authors do not believe it has been performed. Further investigation is warranted, and the results could have major implications. In the absence of any other clinical trial to prove that daratumumab is an effective treatment, we will not recommend the injection of daratumumab for the treatment of relapsed multiple myeloma." - Anonymous Online Contributor
"In a study of patients with MM, only the patient's sex and the presence of an associated plasma cell dyscrasia had a strong and significant association with a specific cause of MM. Data from a recent study are expected to be applicable to other neoplastic diseases. Patients with a specific genetic abnormality may benefit from specific treatments. A multidisciplinary approach may help in making a more definitive diagnosis and selecting a treatment for the patient." - Anonymous Online Contributor
"The increased effectiveness of daratumumab and increased tolerability showed an important superiority over a placebo. The overall study confirms that daratumumab is a valid first line treatment option for newly diagnosed bortezomib-refractory relapsed/refractory/refractory multiple myeloma patients." - Anonymous Online Contributor
"A significant percentage of patients with MM develop MSC. The use of BMPC in MM patients, either as a sole or main therapy, may result in long-term improvement of disease in patients with MM and MSC." - Anonymous Online Contributor