Multiple Myeloma Clinical Trial
Official title:
A Phase 1, Multicenter, Open-label, Dose-Escalation Combination Study of Pomalidomide, Marizomib, and Low-Dose Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma
This is a Phase 1 clinical trial to evaluate a new combination of drugs for the treatment of
relapsed or refractory (drug-resistant) multiple myeloma. The drugs being studied are:
- Pomalidomide (POMALYST®) is a drug that affects the immune system (an immunomodulatory
drug) that has been approved by the United States (US) Food and Drug Administration
(FDA) for the treatment of multiple myeloma.
- Marizomib is an investigational drug being developed by Triphase that is being studied
for the treatment of multiple myeloma. Investigational drugs are drugs that have not yet
been approved by health authorities, such as the FDA, for general use but have been
approved for use in specific clinical studies. Marizomib inhibits a cellular machine
called the proteasome, which destroys unnecessary or damaged proteins. Other proteasome
inhibitors have been shown to be effective in the treatment of multiple myeloma.
- Dexamethasone is a corticosteroid drug that affects the immune system (an
immunomodulatory drug) that has been approved by the FDA for the treatment of multiple
myeloma.
This is the first study to evaluate the three-drug combination of pomalidomide (POM),
marizomib (MRZ), and dexamethasone (LD-DEX) in humans. Pomalidomide, alone or in combination
with dexamethasone, is approved by the FDA for the treatment of relapsed or refractory
multiple myeloma.
The primary objective of this study is to determine the best drug dosing levels for this
three-drug combination, including the highest safe doses and/or the recommended doses for
future clinical studies of this drug combination. The secondary purposes of this study are to
determine the safety of this drug combination and its effectiveness in treating relapsed or
refractory multiple myeloma. The study will include examination of levels of all three drugs
in the blood during various time points during treatment.
n/a
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