By Lizzy Smith | Posted - Apr 7th, 2016

 

 

 

 

CLINICAL TRIAL: Marizomib For Relapsed/Refractory Myeloma

Marizomib

 is a new proteasome inhibitor that is different from bortezomib and carfilzomib. It a recent study published in Blood, it was generally well tolerated and may have clinical activity in previously treated, relapsed or refractory multiple myeloma. One important question for new drugs is always, "How much should be given and what's the best administration?" Phase I studies typically look at a "maximum tolerated dose." Phase II studies typically look at the "optimal" dose.  Researchers ultimately determined that 0.7 mg/m of marizomib infused over 10 minutes and 0.5 mg/m2 infused over 2 hours would be the recommended phase 2 doses for schedule A and B, respectively. In terms of efficacy, 6 patients achieved a clinical benefit response. Of those, 5 had partial responses: 1 patient receiving schedule A (more drug with shorter infusion time) and 4 on schedule B (less drug over longer infusion time). Three of the 4 on schedule B were receiving dexamethasone. Further, these responses were in patients who had received prior bortezomib, lenalidomide, and/or thalidomide. On average, patients in the schedule A group had received approximately 5 prior treatment regimens and those in the schedule B group had received about 7 prior regimens. Results showed the most frequently reported treatment-related adverse events were fatigue, headache, nausea, diarrhea, dizziness, and vomiting. The findings suggest activity of marizomib in this heavily treated population with a minimal number of dose-limiting toxicities. Studies evaluating marizomib in combination with pomalidomide and dexamethasone are currently underway. The Clinical Trial - More Info This Phase 1 clinical trial is evaluating a new combination of drugs for the treatment of relapsed or refractory (drug-resistant) multiple myeloma. The drugs being studied are: Pomalidomide, a drug that affects the immune system; Marizomib, an investigational drug being developed by Triphase. Marizomib inhibits a cellular machine called the proteasome, which destroys unnecessary or damaged proteins; Dexamethasone, a corticosteroid drug that affects the immune system that has been approved by the FDA for the treatment of multiple myeloma. This is the first study to evaluate the three-drug combination 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. For more information on the trial results, visit Cancer Therapy Advisor here. Join This Study Find All Studies for Relapsed/Refractory Myeloma  

 
Lizzy Smith
About the Author

Lizzy Smith - Lizzy Smith was diagnosed with myeloma in 2012 at age 44. Within days, she left her job, ended her marriage, moved, and entered treatment. "To the extent I'm able, I want to prove that despite life's biggest challenges, it is possible to survive and come out stronger than ever," she says.

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