A Study of DKN-01 and Lenalidomide/Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Inclusion Criteria

• •Relapsed or refractory Multiple Myeloma (MM)
• •a. Treated with at least 1 prior regimen for myeloma
• •1. Prior treatment with bortezomib (Velcade) is acceptable with a wash-out of 2 weeks
• •2. Treatment with prior autologous transplant is permitted
• •3. If a transplant is used as consolidation following chemotherapy, without intervening disease progression, it will be considered 1 line of treatment with the preceding chemotherapy
• •Diagnosis of symptomatic MM as defined by the International Myeloma Working Group (IMWG) :
• •1. Second line or greater/Refractory/Relapsed, Stage I, Stage II, Stage III
• •2. Measureable disease as indicated by monoclonal protein in the serum of greater than or equal to (≥) 1 grams per deciliter (g/dL), involved serum free light chain assay ≥10 mg/dL (≥100 mg/L) provided the serum free light chain ratio is abnormal; monoclonal light chain in the urine protein electrophoresis of ≥ 200 mg/24 hours, or measurable plasmacytoma
• •At least 1 osteolytic bone lesion
• •Disease-free of active second/secondary or prior malignancies for equal to or over 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast
• •Ambulatory patients greater than or equal to (≥) 30 years of age
• •Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• •Estimated life expectancy of ≥ 26 weeks
• •Adequate organ function including:
• •1. Hematologic:
• •1. Absolute neutrophil count (ANC) greater than or equal to (≥) 1000/microliter
• •2. Platelet (PLT) count ≥ 75,000/microliter
• •3. Hemoglobin (Hgb) ≥ 8.0 g/dL
• •2. Acceptable coagulation status:
• •1. Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.2 x the upper limit of normal (ULN) unless receiving anticoagulation therapy. If receiving anticoagulation therapy, eligibility will be based upon International Normalization Ratio (INR)
• •2. International normalized ratio (INR) less than or equal to (≤) 1.6 (unless receiving anticoagulation therapy)
• •* If receiving warfarin: INR ≤ 3.0 (and no active bleeding, \[i.e., no bleeding within 14 days prior to first dose of study therapy\])
• •3. Hepatic:
• •1. Bilirubin ≤ 1.5 x ULN
• •2. Alanine Transaminase (ALT) and Aspartate Transaminase (AST) ≤ 2.5 x ULN (if liver metastases are present, then ≤ 5 x ULN is allowed)
• •4. Renal:
• •1. Calculated creatinine clearance ≥ 45 mL using the Cockcroft and Gault Method
• •Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 10 to 14 days and again within 24 hours of starting study drug
• •1. WCBP must agree to have pregnancy tests monthly (every 14 days for women with irregular cycles) while on study drug and 4 weeks after the last dose of study drug
• •2. Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy
• •3. Males and females with reproductive potential must agree to use medically approved contraceptive precautions starting 4 weeks prior to initiation of the therapy and during the trial and for 18 months following the last dose of study drug
• •4. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• •Provide written informed consent prior to any study-specific procedures
• •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures