AL Amyloidosis Clinical Trial
Official 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
preference.
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.
Primary objective:
Determine dose-limiting toxicity (DLT) and the maximal tolerated dose (MTD) of pomalidomide
combined with dexamethasone in subjects with previously- treated light-chain (AL)-amyloidosis
Secondary objectives:
Determine the following at the MTD:
- Hematological complete (CR) very good partial (VGPR) and partial (PR) rates
- duration of response
- organ response
- Time-to-event
- Survival
Exploratory study objective:
To investigate the relationship of changes in the levels of the biomarkers B-type natriuretic
peptide (BNP) and troponin I to frequency of specific adverse events and the occurrence of
DLT
;
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