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Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

Information source: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myeloma

Intervention: Lenalidomide, Dexamethasone, and MEDI-551 (Drug)

Phase: Phase 0

Status: Recruiting

Sponsored by: Sidney Kimmel Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Carol Ann Huff, MD, Principal Investigator, Affiliation: The Johns Hopkins University

Overall contact:
Carol Ann Huff, MD, Phone: 443-287-7104, Email: huffca@jhmi.edu

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.

Clinical Details

Official title: Pilot Study of Lenalidomide and Dexamethasone in Combination With MEDI-551 in Previously Untreated Multiple Myeloma.

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs).

Secondary outcome: The safety of Medi-551 when combined with Lenalidomide and dexamethasone.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

Locations and Contacts

Carol Ann Huff, MD, Phone: 443-287-7104, Email: huffca@jhmi.edu

The Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland 21287, United States; Recruiting
Carol Ann Huff, MD, Phone: 443-287-7104, Email: huffca@jhmi.edu
Carol Ann Huff, MD, Principal Investigator
Additional Information

Starting date: May 2014
Last updated: March 27, 2015

Page last updated: August 23, 2015

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