This phase 1 clinical trial will test the safety of blinatumomab (Blincyto)treatment after high-dose melphalan(Alkeran) and autologous stem cell transplant in patients with refractory (unresponsive to treatment) multiple myeloma. The primary outcome will be measured by the number of adverse (negative) effects. The trial is being conducted in Philadelphia, Pennsylvania.
The details
Chemotherapies, such as melphalan, are often given to damage and kill cancerous blood cells. Autologous stem cell transplants are coupled with the chemotherapy to replace healthy stem cells that may have been damaged. In this procedure, blood stem cells are initially collected from the patient then transplanted back after chemotherapy. While this treatment method can be highly effective, it is possible for cancerous cells to remain in the body. Adding blinatumomab to this treatment may help improve response rates in multiple myeloma patients. It is an immunotherapy that uses the body’s own immune system to identify and kill cancerous B-cells (and potentially plasma cells). It is an antibody (a protein in the immune system) that binds to a protein found on cancerous B-cells, which allows other parts of the immune system to identify the cells as cancerous and initiate an attack.
The study will examine the number of adverse effects in patients for 18 months.
Who are they looking for?
This trial is recruiting 20 patients with refractory multiple myeloma who have received a prior autologous stem cell transplant and progressed within 1 year of infusion. Patients must be able to undergo a second autologous stem cell transplant. Participants should not have previously received an allogeneic (donor) stem cell transplant.
Female participants must not be pregnant or breastfeeding. Both men and women must agree to use contraception. Participants must not have any active infection.
How will it work
Patients will initially undergo a lab procedure to collect blood stem cells and receive high-dose melphalan. The autologous stem cell infusion will occur after the chemotherapy treatment. Two 28-day cycles of intravenous (IV through a vein) blinatumomab infusions will follow.
