Research Study Summary
A clinical research study of Pomalidomide and Dexamthasone for the treatment of AL Amyloidosis
Research Study Title
A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis
This study seeks to enroll patients with AL amyloidosis, for whom treatment with one of the
standard melphalan chemotherapy-based regimens is either not recommended or is not their
Pomalidomide (CC-4047) is a drug given by mouth, which can change or regulate the
functioning of the immune system. So, in theory, it may reduce or prevent the production of
the amyloid protein. Pomalidomide is not currently FDA-approved for AL Amyloidosis.
Pomalidomide is chemically similar to thalidomide and lenalidomide, both of these drugs have
been approved by the FDA for treatment of patients with multiple myeloma (MM), a disease
similar to AL Amyloidosis.
Participants in this study will receive pomalidomide and dexamethasone. Phase I is a
dose-escalation study and dose escalation will proceed through 3 dose-levels according to
standard rules in which dose levels are started sequentially after complete evaluation of
the occurrence of dose-limiting toxicities. In the Phase II portion, participants will
receive pomalidomide and dexamethasone using the defined maximum tolerated dose.
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