A Multicenter Phase 2 Study of the Bruton’s Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Subjects with Relapsed or Relapsed and Refractory Multiple Myeloma
You may be interested in learning about a new clinical trial at Johns Hopkins called Pharmacyclics. In this trial, we are giving a drug called PCI-32765 to patients with multiple myeloma (MM) to learn about its side effects and toxicities, and to see if we can improve the chance that patients who receive it will eventually get a remission. PCI-32765 is a Brutonï¿½s tyrosine kinase (Btk) inhibitor which has shown significant antitumor activity in a broad range of B cell malignancies including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), mantle cell lymphoma (MCL), follicular lymphoma, and lymphoplasmacytic lymphoma.
To join the study, you must have relapsed or refractory multiple myeloma (MM), which means your MM has returned after initial treatment. You must have received at least two prior treatments, one of which must be a drug like Revlimid or Thalidomide. You must be at least 18 years old. Additionally, you must have adequate liver and kidney function, as well as good blood counts and have a good performance status (meaning, you can perform activities of daily living by yourself). To see if you are eligible to take part in this study, you must first sign a consent form to be screened. Then, during screening, a medical history will be taken, a physical exam will be done, and all of your current medications will be reviewed. EXCLUSION CRITERIA - You cannot join this study if you: ï¿½ Have active cardiovascular disease such as arrhythmias, CHF, or heart attack within 6 months of screening ï¿½ Have POEMS syndrome, osteosclerotic myeloma, Crow-Fukase syndrome, plasma cell leukemia, or primary amyloidosis ï¿½ Are receiving denosumab at the same time as the study drug ï¿½ Have used antibiotics for treatment of infection within 7 days prior to screening. ï¿½ Have HIV , hepatitis B, or hepatitis C ï¿½ Have a history of stroke within 6 months. ï¿½ Are lactating or pregnant. ï¿½ Have had any chemotherapy within 3 weeks of the first dose of study drug.
ï¿½ Your PCI-32765 dose will be 420 mg per day. It comes in 140-mg capsules, so you will need to take three of them per day. You must be fasting. One cycle of treatment is 28 days. The drug is given on an outpatient basis. This means you will not be admitted to the hospital for any of your treatment unless there was unexpected problem. ï¿½ During Cycle 1, you must return to clinic on Days 1, 2, 8, 15, and 22. During Cycles 2 through 12, you must return to clinic once a month, on Day 1. After 12 months on study, you can return every other month (on Day 1) for your visit. ï¿½ Throughout your time on the study, you will have medication and side effect reviews, neuropathy and bone pain assessments, physical exams, vital sign assessments, blood sample collection for routine blood tests (including hematology, chemistry, and coagulation), urine sample collection, and myeloma-specific tests such as X-rays, ï¿½2-Microglobulin, Ig Panel, Serum IFE, Freelite, SPEP and UPEP, pregnancy tests for females of child bearing potential, and a bone marrow aspirate and/or biopsy. ï¿½ You will also have study-specific research blood samples taken. This includes two days during Cycle 1 where you will be required to stay on-site for 7 hours after you take your study drug in the morning. These are called ï¿½PKï¿½ days, which stands for ï¿½pharmacokineticsï¿½ ï¿½ meaning we look at how the drug is being processed in your body at different time intervals. This will happen on Day 1 and Day 8 of Cycle 1. Another research blood sample (called a bone turnover test) requires you to fast for 12 hours prior to the sample being drawn. This is required on Cycle 1, Day 1, as well as Day 1 of every even-numbered cycle afterwards. ï¿½ Based on initial response to study drug, certain subjects will have the option of receiving dexamethasone 40 mg orally weekly in addition to PCI-32765. If this occurs, you will have additional ï¿½PKï¿½ days required during one cycle of treatment. ï¿½ If you have questions about your eligibility for this study, please contact your Johns Hopkins physician.
09/21/2014 04:03 AM