Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study is being done to see if combining the investigational chemotherapy drug, MEDI-551 with the known anti-myeloma drugs, Lenalidomide and Dexamethasone will reduce your myeloma cancer stem cells.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: MedImmune LLC
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Thalidomide

Criteria

Inclusion Criteria:

• Age 18 to 100 years at the time screening

• Symptomatic, previously untreated (with exception of corticosteroids) secretory myeloma

• 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 therapy.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

• Life expectancy of >6 months

• Serum creatinine ≤ 2

• ANC≥1000

• Platelets ≥ 50,000

• Total bilirubin ≤ 2 x upper limit of normal (ULN)

• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x ULN

• Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin)

Exclusion Criteria:

• Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of patient safety or study results.

• Concurrent enrollment in another clinical study, except for non-interventional, observational studies.

• 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 cluster of differentiation antigen 19 (CD19).

• 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 syndrome.

• 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