Daratumumab After Stem Cell Transplant for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies how well daratumumab after a stem cell transplant works in treating patients with multiple myeloma. Monoclonal antibodies, such as daratumumab, may kill cancer cells that are left after chemotherapy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on chemotherapy, biologic, or hormonal therapy for cancer treatment while participating. It's best to discuss your specific medications with the trial team.
Is daratumumab safe for use in humans?
Daratumumab, also known as Darzalex, has been shown to have an acceptable safety profile in multiple studies for treating multiple myeloma. Common side effects include low blood cell counts and infusion-related reactions, but it generally does not increase overall toxicity when used in combination with other treatments.12345
How does the drug daratumumab differ from other treatments for multiple myeloma?
Daratumumab is unique because it is a monoclonal antibody that specifically targets CD38, a protein found on multiple myeloma cells, and it can be used both as a monotherapy and in combination with other drugs. It works through several mechanisms, including directly killing cancer cells and modifying the immune system, and is available in both intravenous and subcutaneous forms, offering flexibility in administration.12367
What data supports the effectiveness of the drug Daratumumab for multiple myeloma?
Daratumumab, when used in combination with other drugs, has been shown to significantly improve patient outcomes in multiple myeloma, such as increasing the rate of complete response and prolonging the time patients live without the disease getting worse. This has been demonstrated in several clinical trials, including the CASSIOPEIA and ALCYONE trials.12367
Who Is on the Research Team?
Amrita Y. Krishnan
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for patients with multiple myeloma who have adequate organ function, no severe asthma or uncontrolled diseases, and are not pregnant. They must understand the study and agree to use birth control. Participants should be within 2-13 months of their first therapy for multiple myeloma and have a sufficient number of stem cells collected for transplant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive daratumumab intravenously every week for 8 weeks, every 2 weeks for 16 weeks, and then every 4 weeks for up to 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator