Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma

Exclusion Criteria

• •1. Currently receiving or have received systemic cancer therapy (chemotherapy, biologic therapy) ≤ 21 days of initiating study therapy. For patients receiving small molecule targeted therapy, study treatment may begin \>21 days after last dose or \>5 half lives of previous treatment, whichever is shorter. Patients must have completed radiation therapy ≥7 days prior to starting study treatment. Patients must have recovered from or come to a new chronic stable baseline from all treatment-related toxicities. Dexamethasone or other high-dose steroid therapy must be stopped ≥ days prior to starting study treatment.
• •2. Previous treatment with HDAC, DAC, HSP90 or valproic acid for treatment of cancer.
• •3. Requires valproic acid for any medical condition during the study ≤5 days prior to first panobinostat treatment.
• •4. Patient has not recovered from all therapy-related toxicities associated with prior treatments to \< Grade 2 CTCAE.
• •5. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib).
• •6. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis ≤14 days prior to study entry.
• •7. Patients using medications that have a risk of prolonging the QT interval or inducing Torsade de Pointes if treatment cannot be discontinued or switched to a different medication prior to receiving study drug.
• •8. Patients with \> grade 2 diarrhea.
• •9. Patients with impaired cardiac function.
• •10. Infection requiring IV antibiotics.
• •11. Patients with \> grade 2 peripheral neuropathy or with uncontrolled pain.
• •12. Women who are pregnant or lactating.
• •13. Any concurrent medical illness that may impair the ability of the patient to tolerate study treatment and comply with the requirements of the study.
• •14. Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
• •15. Use of any non-approved or investigational agent ≤30 days prior to administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
• •16. Presence of other active cancers, or history of treatment for invasive cancer ≤ 5 years. Patients with stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e. non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.