Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma

Exclusion Criteria

• •Grade 2 or greater peripheral neuropathy within 14 days before enrollment
• •Renal insufficiency (serum creatinine \> 2.5 mg/dL)
• •Evidence of mucosal or internal bleeding and/or platelet refractory
• •ANC \< 1000 cells/mm3
• •Hemoglobin \< 8.0 g/dL
• •AST or ALT greater than or equal to 2 x ULN
• •Concomitant therapy medications that include corticosteroids
• •Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• •Clinically relevant active infection or serious co-morbid medical conditions
• •Prior malignancy (within last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or breast cancer, in situ prostate cancer
• •Pregnant or breast-feeding
• •Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• •Uncontrolled diabetes mellitus
• •Hypersensitivity to acyclovir or similar anti-viral drug
• •POEMS syndrome
• •Known HIV infection
• •Known active hepatitis B or C viral infection
• •Known intolerance to steroid therapy
• •Subjects with primary refractory disease, defined as progression during initial treatment