Phase II Study of Infusional Carfilzomib in Patients With Relapsed or Refractory Multiple Myeloma
- Participants must meet all of the following inclusion criteria to be eligible to
enroll in this study.
- Patients meeting the criteria for symptomatic multiple myeloma that has relapsed or
is refractory to at least 2 prior lines of therapy.
- Previous therapy with bortezomib.
- Previous therapy with thalidomide or lenalidomide.
- Patients must have measurable disease and therefore must have at least one of the
Serum M-protein ≥1 gm/dL (≥10 gm/L) Urine M-protein ≥200 mg/24 hr Serum FLC assay:
involved FLC ≥10 mg/dL (≥100 mg/L) provided serum FLC ratio is abnormal.
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Adequate hepatic
function, with serum ALT ≤ 3.5 times the upper limit of normal and serum direct
bilirubin ≤ 2 mg/dL (34 µmol/L) within 14 days prior to enrollment
- Absolute neutrophil count (ANC) ≥ 1.0 × 109/L within 14 days prior to enrollment
Hemoglobin ≥ 8 g/dL (80 g/L) within 14 days prior to enrollment (participants may be
receiving red blood cell [RBC] transfusions in accordance with institutional
- Platelet count ≥ 50 × 109/L (≥ 30 × 109/L if thought to be secondary to myeloma
involvement of the bone marrow ) within 14 days prior to enrollment (platelet
transfusions are allowed)
- Creatinine clearance (CrCl) ≥ 15 mL/minute within 14 days prior to enrollment, either
estimated or calculated using a standard formula (eg, Cockcroft and Gault)
- Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and
to practice contraception.
- Male participants must agree to practice contraception.
- Prior treatment with carfilzomib.
- Known CNS involvement with myeloma
- Pregnant or lactating females
- Major surgery within 21 days prior to registration.
- Acute active infection requiring treatment (systemic antibiotics, antivirals, or
antifungals) within 7 days prior to enrollment
- Known human immunodeficiency virus infection
- Active hepatitis B or C infection
- Unstable angina or myocardial infarction within 4 months prior to enrollment, NYHA
Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular
arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia
or Grade 3 conduction system abnormalities unless participant has a pacemaker
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to
- Concurrent malignancies, except for treated non-melanoma skin cancer and cervical
carcinoma in situ.
- Significant neuropathy (Grades 3-4, ) within 14 days prior to enrollment
- Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize
- Contraindication to any of the required concomitant drugs or supportive treatments,
including options, antiviral drugs, or intolerance to hydration due to preexisting
pulmonary or cardiac impairment
- Concurrent therapy with any other anticancer therapeutic with activity against
- Concurrent therapy with investigative agents (e.g., antibiotics or antiemetics)