S1304, Carfilzomib and Dexamethasone for Treating Patients With Relapsed or Refractory Myeloma

Inclusion Criteria

• REGISTRATION STEP 1: INITIAL RANDOMIZATION
• Patients must have a confirmed diagnosis of symptomatic multiple myeloma and must be currently relapsed or refractory; all tests for establishing disease status must be completed within 28 days prior to registration and documented on the Baseline Tumor Assessment Form for Multiple Myeloma
• Patients must have measurable disease within 28 days prior to registration
• Patients must have received at least one prior regimen of chemotherapy for symptomatic multiple myeloma; patients may not have more than six (6) previous regimens of therapy for the disease; prior chemotherapy must have been completed at least 21 days prior to registration; for study purposes, a regimen is defined as follows:
• An anti-myeloma therapy used at the time of initial diagnosis or documented disease progression which is given with the intent to decrease disease burden
• Any maintenance therapy used after an Induction should be considered part of that Induction regimen
• Use of any agent or combination of agents more than once during the patient's disease history for separate documented disease progressions will be counted as separate regimens (e.g., if a patient receives lenalidomide/bortezomib at initial diagnosis and achieves response, but then progresses and receives lenalidomide/bortezomib after progression, these count as 2 separate regimens)
• In cases of allogeneic or autologous stem cell transplant, the entire induction + stem cell mobilization + conditioning + planned maintenance should be considered one regimen
• Patients may not have received any prior carfilzomib treatment
• Patients must not be receiving any other concurrent therapy considered to be investigational; patients must not be planning to receive any radiotherapy (except localized radiation for palliative care); patients must not be planning to receive any concurrent chemotherapy, immunotherapy, radiotherapy or other treatment with curative intent
• Patients must have complete history and physical examination within 28 days prior to registration
• Patients must have baseline PET scan within 28 days prior to registration; note that images are submitted centrally for review
• Patients with non-secretory MM or known primary amyloidosis are not eligible
• Patients must have Zubrod performance status 0-2
• Patients must not have clinically significant illness including uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, or >= grade 3 cardiac arrhythmias
• Patients must have undergone an electrocardiogram (EKG) within 28 days prior to registration
• Patients must have either echocardiogram (ECHO) with ejection fraction >= 45% within 28 days prior to registration
• Patients must not have > grade 2 neuropathy and/or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
• Total bilirubin = = 1, 000 cell/mm^3 without growth factor support within 14 days prior to registration
• Platelets >= 50, 000 cells/mm^3 for patients who have bone marrow plasmacytosis = 30,000 cells/mm^3 for patients who have bone marrow plasmacytosis of >= 50% within 14 days prior to registration
• Calculated or measured creatinine clearance >= 30 ml/min within 14 days prior to registration
• Patients who are known to be human immunodeficiency virus positive (HIV+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration:
• Cluster of differentiation (CD)4 cells >= 500/mm^3
• Viral load of 10% from baseline (as determined by ECHO) or other ejection fraction decrease accompanied by other clinical signs/symptoms of New York Heart Association (NYHA) class III or IV heart failure, measured within 28 days prior to registration; if any question exists regarding individual patien