Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

NCT ID: NCT01861340

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-07-31

Brief 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.

Detailed Description

To explore the effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs). Myeloma CSCs will be assessed by a clonogenic assay from the bone marrow and flow cytometry from peripheral blood.

Conditions

Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lenalidomide, Dexamethasone, and MEDI-551

Eligible patients will receive Lenalidomide and dexamethasone as per standard of care guidelines for 2 cycles. Patients with a clinical response to lenalidomide and dexamethasone after 2 cycles will proceed to get MEDI-551 for 2 cycles. MEDI-551 will be dosed at 4mg/kg IV on days 1 and 8 of cycle 3 and 4mg/kg IV on day 1 of cycle 4.

Group Type: EXPERIMENTAL

Lenalidomide, Dexamethasone, and MEDI-551

Intervention Type: DRUG

Patients will receive Lenalidomide and dexamethasone as per standard of care. Patients with a clinical response after 2 cycles will get 2 cycles of MEDI-551.

Interventions

Lenalidomide, Dexamethasone, and MEDI-551

Patients will receive Lenalidomide and dexamethasone as per standard of care. Patients with a clinical response after 2 cycles will get 2 cycles of MEDI-551.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol Ann Huff, MD

Role: PRINCIPAL_INVESTIGATOR

The Johns Hopkins University

Locations

The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00081182

Identifier Type: OTHER

Identifier Source: secondary_id

J1340

Identifier Type: -

Identifier Source: org_study_id