Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

Completed · Early Phase 1

Conditions studied: Myeloma

In brief

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.

Key facts

Study ID

NCT01861340

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

20

Starts

2014-05-01

Expected to finish

2016-07-01

Last updated by the study team

2018-09-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• The Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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