Study of Pomalidomide, Cyclophosphamide, Dexamethasone in Relapsed/Refractory Multiple Myeloma
Status:
Completed
Trial end date:
2019-05-07
Target enrollment:
Participant gender:
Summary
This study is being done to learn more about the drug, pomalidomide and to gather data on its
safety and side effects when used in combination with commercially available cyclophosphamide
and dexamethasone. This combination is considered experimental and has not been approved by
the FDA.
Pomalidomide is a third generation immunomodulatory (IMiDs) agent, which is a more potent
version of thalidomide and lenalidomide drugs that have been approved by the United States
Food and Drug Administration [FDA] for the treatment of MM. In February 2013, pomalidomide
was also approved by the FDA for patients with MM who have had more than 2 types of therapy.
Pomalidomide is taken orally as capsules, and cyclophosphamide and dexamethasone are also
taken orally as tablets in this study. Cyclophosphamide and dexamethasone are commercially
available and are often used in combination with other drugs to treat Multiple Myeloma.
Preliminary data from both the laboratory and patient studies suggest that this combination
of drugs is more effective than pomalidomide and dexamethasone alone. However, the regimen
being used in this study, which consists of daily cyclophosphamide, also permits support of
low blood counts with either injections or transfusions as needed.