Daratumumab for Multiple Myeloma
This study is evaluating whether a drug called selinexor can be used to treat multiple myeloma.
See full descriptionAbout the trial for Multiple Myeloma
Treatment Groups
This trial involves 3 different treatments. Daratumumab is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
About The Treatment
Eligibility
This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Daratumumab will improve 1 primary outcome, 6 secondary outcomes, and 3 other outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 2 years.
Patient Q & A Section
Have there been any new discoveries for treating multiple myeloma?
There have not been any significant advances in MM treatment over the last 5 years. Clinical trials targeting proteasome inhibitors in combination with anthracyclines are ongoing. Targeting T-cell activating ligands such as CD40L has potential, but additional studies are needed. Monoclonal antibodies targeting cell adhesion molecules such as VCAM-1 or ICAM-1 may be beneficial in MM patients who are refractory to conventional chemotherapy. Further study of monoclonal antibodies directed against VCAM-1 and ICAM-1 will be important in this area. Gene therapy is being investigated in MM. The evaluation of immunotherapeutic agents and vaccines is underway.
How does daratumumab work?
Daratumumab is effective in reducing tumor mass in patients with relapsed or refractory multiple myeloma who have been treated with at least two prior therapies. Treatment-related toxicity was limited to infusion reactions and infections.
Can multiple myeloma be cured?
Multiple myeloma can be cured with current chemotherapy regimens. However, the long-term outcome remains poor due to frequent relapse. The 5-year survival rate ranges from 17% to 33%, depending on the initial disease staging and the patient's age. In addition, patients with <5% plasma cell fraction at diagnosis have a significantly longer survival time than those who have >5%. It is recommended that physicians consider excluding patients with <5% plasma cells from clinical trials, unless they are carefully selected in the context of clinical trial protocols (e.g., age ≤60 years seems to be associated with better prognoses).
What is the survival rate for multiple myeloma?
As we are living in a modern age where [chemotherapy] is commonly used, this exact treatment is very possible. The overall 5-year survival rate for patients diagnosed with MM was 78.3%. However, if the patient survived 5 years, 98% would still survive 10 years, and 85% would still survive 20 years.
Is daratumumab typically used in combination with any other treatments?
Daratumumab is typically used in combination with other treatments, including chemotherapy, immunotherapy, and biologic therapy. The most common combination is daratumumab plus dexamethasone followed by daratumumab monotherapy or daratumumab plus lenalidomide followed by lenalidomide monotherapy. The use of daratumumab monotherapy was associated with shorter overall survival than other combinations. Daratumumab should be considered only when other options have failed to improve survival.
What is multiple myeloma?
Multiple myeloma correlates strongly with the presence of trauma, particularly sexual trauma. Results from a recent clinical trial demonstrate the need for routine screening for criminal history and sexual abuse among men presenting with multiple myeloma.
How serious can multiple myeloma be?
There is not enough data to conclude how serious multiple myeloma is. However, patients should be aware that the likelihood of death from multiple myeloma increases if there are unexplained fever, blood loss, or bone pain. Patients should discuss their cancer history with their doctor on a regular basis.
What are the chances of developing multiple myeloma?
The European population (excluding Poland) had a 1 in 16 chance of having MM compared to the United States where it was 1 in 50. This implies that approximately 1 in 3 persons in Europe develop MM. It takes about 4 years after diagnosis of MM before initiating treatment. No differences were found between countries in MM survival and MM-related mortality.
What are the signs of multiple myeloma?
Multiple myeloma causes an increase in bone fractures, high blood calcium levels, and low blood platelet counts. In addition, individuals with MM may experience pain or numbness in small areas of the body due to bone lesions. With treatment, these changes usually disappear; however, they may return if the disease progresses. Other common signs and symptoms include fatigue, feeling tired all the time, hair loss or thinning, weight loss, or swelling (edema). Bone marrow aspiration and biopsy can assist in making the diagnosis of myeloma. It is important to remember that multiple myeloma may be misdiagnosed as another type of bone cancer, osteosarcoma. Differential diagnoses also include lymphoma.
What is daratumumab?
Dara-T is an antibody targeting CD20 (a B cell marker), which has shown significant antitumor activity in combination with lenalidomide and dexamethasone in multiple myeloma. The FDA approved this drug on August 5, 2013.\n