Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Exclusion Criteria

• •Patients for whom there is the prospect of stem cell transplantation in the next 6 months in the treatment plan are excluded
• •POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• •Plasma cell leukemia
• •Waldenström's macroglobulinemia or immunoglobulin M (IgM) myeloma
• •Radiotherapy to multiple sites or immunotherapy within 4 weeks before start of protocol treatment (localized radiotherapy to a single site at least 1 week before start is permissible)
• •Participation in an investigational therapeutic study within 3 weeks or within 5 drug half lives (t1/2) prior to first dose, whichever time is greater
• •Patients known to be refractory to any proteasome inhibitor other than bortezomib or carfilzomib
• •Pregnant or lactating
• •History of allergy to mannitol or prior hypersensitivity to thalidomide, lenalidomide or pomalidomide
• •Major surgery within 3 weeks prior to first dose,
• •Prior peripheral stem cell transplant within 12 weeks of study enrollment
• •Has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal (with the exception of hormones for thyroid conditions or estrogen replacement therapy \[ERT\]), or any investigational therapy within 21 days of enrollment
• •Myocardial infarction within 6 months prior to enrollment, New York Heart Associate (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• •Uncontrolled hypertension or diabetes
• •Acute active infection requiring systemic antibiotics, antivirals, or anti fungals within two weeks prior to first dose
• •Known or suspected human immunodeficiency (HIV) infection, known HIV seropositivity
• •Active hepatitis A, B, or C infection
• •Non-hematologic malignancy within the past 3 years except adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix or breast, prostate cancer \< Gleason grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone
• •Any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
• •Significant neuropathy (grades 3-4, or grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment
• •Contraindications to any of the required concomitant drugs, including proton-pump inhibitor (eg, lansoprazole), enteric-coated aspirin, allopurinol or if a history of prior thrombotic disease, warfarin or low molecular weight heparin
• •Subjects in whom the required program of PO and IV fluid hydration is contraindicated, eg, due to pre-existing pulmonary, cardiac, or renal impairment
• •Subjects with known or suspected amyloidosis of any organ
• •Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis
• •Prior exposure to daratumumab