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Abstract
In this research study, we will learn about the safety of the drug Darzalex® (daratumumab) in patients with antiphospholipid syndrome (APS), and will also learn whether it reduces levels of the antiphospholipid antibodies that cause APS.
What is Antiphospholipid Syndrome?
Antiphospholipid syndrome (APS) is a rare and chronic autoimmune disorder that occurs when the body’s immune system mistakenly attacks healthy tissues and organs. Phospholipids are present on the surface of cells, including blood cells and cells that line blood vessels. In some people, the immune system makes antibodies to proteins that bind to phospholipids. These antiphospholipid antibodies attack the body and may increase the risk of blood clots in veins or arteries, and the risk of miscarriage or stillbirth.
About the Study Drug
Daratumumab is an antibody that targets a protein called CD38, which is on the surface of the immune cells that produce antiphospholipid antibodies (plasmablasts and plasma cells). In APS, daratumumab may work by eliminating these antiphospholipid antibody-producing cells, thereby reducing damage to the body caused by antiphospholipid antibodies.
Daratumumab is currently approved by the U.S. Food and Drug Administration (FDA) to treat a blood cancer called multiple myeloma. However, it has not been tested in patients with APS, and is considered an experimental treatment in the DARE-APS study.
Participating in DARE-APS
Participation in DARE-APS will occur in two phases. During the treatment phase, participants will receive 8 weekly intravenous (IV) doses of daratumumab. The post-treatment follow-up phase will last an additional 10 months, during which 6 monitoring clinic visits will occur.
About This Study
In this research study, we will learn about the safety of the drug Darzalex® (daratumumab) in patients with antiphospholipid syndrome (APS), and will also learn whether it reduces levels of the antiphospholipid antibodies that cause APS.
What is Antiphospholipid Syndrome?
Antiphospholipid syndrome (APS) is a rare and chronic autoimmune disorder that occurs when the body’s immune system mistakenly attacks healthy tissues and organs. Phospholipids are present on the surface of cells, including blood cells and cells that line blood vessels. In some people, the immune system makes antibodies to proteins that bind to phospholipids. These antiphospholipid antibodies attack the body and may increase the risk of blood clots in veins or arteries, and the risk of miscarriage or stillbirth.
About the Study Drug
Daratumumab is an antibody that targets a protein called CD38, which is on the surface of the immune cells that produce antiphospholipid antibodies (plasmablasts and plasma cells). In APS, daratumumab may work by eliminating these antiphospholipid antibody-producing cells, thereby reducing damage to the body caused by antiphospholipid antibodies.
Daratumumab is currently approved by the U.S. Food and Drug Administration (FDA) to treat a blood cancer called multiple myeloma. However, it has not been tested in patients with APS, and is considered an experimental treatment in the DARE-APS study.
Participating in DARE-APS
Participation in DARE-APS will occur in two phases. During the treatment phase, participants will receive 8 weekly intravenous (IV) doses of daratumumab. The post-treatment follow-up phase will last an additional 10 months, during which 6 monitoring clinic visits will occur.
Do you Qualify for this Clinical Trial?
You may be eligible to participate in DARE-APS if you:
- Are between ages 18 and 65
- Have a diagnosis of antiphospholipid syndrome (APS)
- Do not have lupus
- Have had at least one of the following clinical problems related to APS within the past 5 years:
- Blood clot
- Pregnancy loss or pregnancy complications
- Skin disease
- Lung disease
- Kidney disease