This phase 2 trial is evaluating how well daratumumab (Darzalex) works in treating patients with multiple myeloma (MM) that has come back after a stem cell transplant (SCT). The main outcome to be measured will be the number of patients who have a complete disappearance of all signs of cancer. This trial is recruiting in Houston, Texas.
Multiple myeloma (MM) is a type of cancer of the bone marrow that can lead to abnormal immune cells. High-dose chemotherapy followed by SCT is a key part of initial treatment. Some patients may have the cancer come back after SCT. Alternative treatment options are needed for these patients. One option is daratumumab, an immunotherapy drug. This type of treatment can block cancer cell growth. This leads to cancer cell death.
This study is evaluating how well daratumumab works in treating patients with MM that has come back after SCT. The main outcome to be measured will be the number of patients who have a complete disappearance of all signs of cancer (complete response). The number of patients who live without tumor growth or spread (progression-free survival) will also be measured.
Who are they looking for?
This study is recruiting 56 patients with relapsed MM. To participate in this study, patients must have had relapse before or after a previous SCT procedure. Patients must have adequate blood cell counts and liver and kidney function and must have recovered from side effects from previous treatments.
Patients who have had major surgery or radiotherapy within 2 weeks of starting the study cannot participate. Female patients who are pregnant or breastfeeding cannot participate. Patients with chronic lung disease, heart failure or abnormal heart rhythm cannot participate. Patients who have had an infection that required antibiotics within 1 week of starting the study cannot participate. Patients who had daratumumab before and could not tolerate it cannot participate. Patients cannot have HIV, hepatitis or other serious medical conditions.
How will it work
All patients will receive daratumumab at 60 to 120 days after undergoing SCT. Patients will receive 6 courses of treatment. Courses will repeat every 28 days for up to 2 years. 3 months after SCT, patients will receive daratumumab maintenance therapy. Maintenance therapy is a low-dose treatment given over a long period of time to delay relapse.
The main outcome to be measured will be the number of patients who have a complete response to treatment. The number of patients who survive without tumor growth or spread after treatment will also be measured. Patients will be followed up at 1 month and 3 months after finishing treatment. Then, patients will be followed-up again every 4 to 12 weeks. Overall, patients will be followed up for 2 years.