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Daratumumab, Pomalidomide and Dexamethasone (DPd) in Relapsed/Refractory Light Chain Amyloidosis Patients Previously Exposed to Daratumumab

Clinical Trial Details

The purpose of this study is to assess the efficacy of this combination of drugs in light chain (AL) amyloidosis which has relapsed or become refractory to other treatments. Amyloidosis is a rare disease that is caused by a substance called amyloid. Amyloid is an abnormal protein produced by plasma cells in the bone marrow which cannot be broken down by the body and so accumulate over time in various organs. Amyloidosis can affect different organs in different people. The most commonly affected organs are the heart, kidney, liver, spleen, nervous system, and digestive tract. Patients with amyloidosis might feel very tired and weak, short of breath, and dizzy. They might develop leg swelling, tongue swelling, numbness and tingling in the hands and feet, and/or increased bruising and bleeding.
   
This research study is being done because currently, there is no cure for amyloidosis. However, treatment with chemotherapy can stop the growth of abnormal plasma cells that produce this abnormal protein. The decrease in amyloid protein in the body leads to improvement in the function of involved organs. There are several treatment options available to patients with amyloidosis. Therapy options are based on the overall health, which organs are affected and how poorly do they work.
   
Daratumumab (Faspro) is a monoclonal antibody given via injection just under the skin in the abdomen that attaches to plasma cells making amyloid and tells the immune system to attack them. This action by the body can slow down or eliminate plasma cell growth and thus the amyloid production and accumulation. Daratumumab is approved to be given as an injection under the skin in both AL amyloidosis which is newly diagnosed and multiple myeloma. Daratumumab has been shown to be very effective in relapsed refractory AL amyloidosis, where it was first studied, but its repeat use in AL amyloidosis patients who have previously received daratumumab in the past is considered investigational.
   
Pomalidomide is an anticancer drug (called an immunomodulatory drug) that works by activating the immune system to fight plasma cells making amyloid. It has been used for therapy in AL amyloidosis for this purpose.
   
Dexamethasone is a synthetic (man-made) steroid taken by mouth that is used in the treatment of AL amyloidosis. Dexamethasone appears to cause cell death in many types of blood cancer cells, including plasma cells.

 

Key Eligibility: 

Inclusion Criteria (selected):

  • Diagnosis of primary AL amyloidosis
  • Relapsed and/or refractory AL amyloidosis
  • Measurable disease by circulating serum light chains
  • Has received daratumumab IV or by injection (Faspro) as a prior treatment for AL amyloidosis
  • Has not received pomalidomide as prior treatment for AL amyloidosis

Detailed eligibility reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Kathleen Pogonowski, RN
(646) 962-6500
kap9111@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1912021159

ClinicalTrials.gov:

NCT04270175

Status

Open to Enrollment

Age Group

Adult

Sponsor