Pilot Study of Lenalidomide and Dexamethasone in Combination With MEDI-551 in Previously Untreated Multiple Myeloma.
- Age 18 or older at the time screening
- Symptomatic, previously untreated (with exception of corticosteroids) secretory
- Written informed consent obtained from the patient/legal representative prior to
performing any protocol-related procedures, including screening evaluations
- Patient must agree to take Lenalidomide with low dose dexamethasone as their initial
- ECOG performance status of 0, 1, or 2.
- Life expectancy of >6 months
- Serum creatinine ≤ 2
- Platelets ≥ 50,000
- Total bilirubin ≤ 2 x ULN
- AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients
intolerant to ASA may use warfarin or low molecular weight heparin)
- Any condition that, in the opinion of the investigator, would interfere with
evaluation of the investigational product or interpretation of patient safety or
- Concurrent enrollment in another clinical study, except for non-interventional,
- Any chemotherapy, immunotherapy, biologic, investigational, for treatment of multiple
myeloma other than Lenalidomide and dexamethasone.
- Previous monoclonal antibody (mAb) or other treatment specifically directed against
- History of serious allergy or reaction to any component of the MEDI-551 formulation
that would prevent administration.
- Previous systemic cancer therapy for myeloma.
- Any active secondary malignancy.
- Human immunodeficiency virus (HIV) positive serology or acquired immune deficiency
- Active hepatitis B as defined by seropositivity for hepatitis B surface antigen. Or
patients with positive hepatitis B core antibody titers.
- Patients with hepatitis C antibody will be eligible provided that they do not have
elevated liver transaminases or other evidence of active hepatitis.
- Documented current central nervous system involvement by multiple myeloma.
- Previous medical history or evidence of an intercurrent illness that may, in the
opinion of the investigator, compromise the safety of the patient in the study.
- Diagnosis of plasma cell leukemia
- Diagnosis of POEMS syndrome
- Diagnosis of Amyloidosis
- Diagnosis of non-secretory myeloma