| Exclusion Criteria: | 1) Multiple Myeloma IgM
2) Subjects who failed to achieve at least a confirmed MR (>/= 25 % reduction in M-protein for >/= 6 weeks) on any of their prior treatment regimens.
3) Subject with non-secretory multiple myeloma, defined as <1g/dL M-protein in serum and <200mg/24hr M-protein in urine.
4) Subjects with disease measurable only by serum free light chain (SFLC) analysis.
5) Glucocorticoid therapy (prednisone > 10 mg/day orally or equivalent) within the last three weeks.
6) POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
7) Plasma cell leukemia.
8) Chemotherapy with approved or investigative anticancer therapeutics including steroid therapy within the three weeks prior to first dose.
9) Radiation therapy or immunotherapy in the previous four weeks; localized radiation therapy within 1 week prior to first dose.
10) Participation in an investigational therapeutic study within three weeks or within five drug half-lives (t1/2) prior to Day 1, whichever time is greater.
11) Prior treatment with carfilzomib.
12) Major surgery within three weeks before Day 1.
13) Congestive heart failure (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction in the previous six months.
14) Acute active infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose
15) Known or suspected HIV infection or subjects who are HIV seropositive.
16) Active hepatitis A, B, or C infection
17) Non-hematologic malignancy within the past three years except a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c) prostate cancer <Gleason Grade 6 with stable PSA.
18) Subjects with treatment related myelodysplastic syndrome.
19) Significant neuropathy (Grade 3, 4 or Grade 2 with pain) at the time of study initiation.
20) Subjects in whom the required program of oral and intravenous fluid hydration is contraindicated, e.g., due to pre-existing pulmonary, cardiac or renal impairment.
21) Subjects with known or suspected amyloidosis
22) Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis
23) Female subjects who are pregnant or lactating.
24) Serious psychiatric or medical conditions that could interfere with treatment.
25) 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. |