Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients
Status:
Active, not recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this clinical research study is to evaluate the safety and effectiveness (good
and bad effects) of pomalidomide given as part of a combination therapy that include more
than just steroids to treat subjects with relapsed (subjects whose disease came back) or
refractory (subjects whose disease did not respond to past treatment) multiple myeloma (MM).
Pomalidomide (alone or in combination with dexamethasone) has been approved by the United
States Food and Drug Administration (FDA) for the treatment of MM patients who have received
at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated
disease progression on or within 60 days of completion of their last therapy. However, the
use of pomalidomide in combination with other drugs used to treat MM, such as
chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not
approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like
lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere
with the development of small blood vessels that help support tumor growth. Therefore, in
theory, it may reduce or prevent the growth of cancer cells. The testing done with
pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM
both on its own and in combination with dexamethasone. Using another drug class, namely
proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor with
another in an established anti-myeloma treatment regimen can frequently overcome resistance
regardless of the other agents that are part of the anti-myeloma regimen. Importantly, the
toxicity profile of the new combinations closely resembled that of the proteasome inhibitor
administered as a single agent. Based on this experience, we hypothesize that the replacement
of lenalidomide with pomalidomide will yield similar results in a similar relapsed/refractory
MM patient population.