Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma
Conditions
Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 0
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Intervention
Name: Lenalidomide, Dexamethasone, and MEDI-551
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.

- 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 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)

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 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
Location
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Status: Recruiting
Contact: Carol Ann Huff, MD - 443-287-7104 - huffca@jhmi.edu
Start Date
May 2014
Completion Date
April 2016
Sponsors
Sidney Kimmel Comprehensive Cancer Center
Source
Sidney Kimmel Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page