Clinical Trial (Relapsed/Refractory Myeloma) - Phase 1b Ricolinostat with Pom & Low-Dose Dex
We love Spark Cures (www.sparkcures.com), perhaps our favorite site for finding myeloma-specific clinical trials in a very simple way. Here is one trial that is currently enrolling patients. CLINICAL TRIAL: ACY-1215 in Combination With Pomalidomide and Low-dose Dex in Relapsed-and-Refractory Multiple Myeloma
What is the purpose of this trial?
Phase 1b: To evaluate the side effects and determine the best dose of ACY-1215 in combination with Pomalidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma. Phase 2: To determine the overall response rate of ACY-1215 in combination with Pomolidomide and low-dose dexamethasone in patients with relapsed-and-refractory multiple myeloma.
EnrollmentApprox. 100 patients will be enrolled in this study
Who Sponsors this trial?Acetylon Pharmaceuticals Incorporated
You may be eligible if you meet the following criteria:Inclusion Criteria:
- Must have a documented diagnosis of multiple myeloma and have relapsed-and-refractory disease. Patients must have received at least 2 lines of prior therapies. Patients must have relapsed after having achieved at least stable disease (SD) for at least one cycle of treatment to at least one prior regimen and then developed progressive disease (PD). Patients must also have documented evidence of PD during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry (refractory disease)
- Must have undergone prior treatment with at least 2 cycles of lenalidomide and at least 2 cycles of a proteasome inhibitor (either in separate regimens or within the same regimen)
- Must not be a candidate for autologous stem cell transplant (ASCT), has declined the option of ASCT, or has relapsed after prior ASC
- Must have measurable levels of myeloma paraprotein in serum (? 0.5 g/dL) or urine (? 0.2 g/24 hours)
- Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Females of child bearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to, and again within 24 hours of starting pomalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking pomalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods,and Education and Counseling Guidance must be followed per protocol
- Must be able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulated, with an international normalized ratio (INR) of 2 to 3