Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01861340
• Other study ID #: J1340
• Secondary ID: NA_00081182
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	The Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The pharmacodynamics (reduction in B cells) of this combination		28 weeks
Primary	The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs).		16 weeks
Secondary	The safety of Medi-551 when combined with Lenalidomide and dexamethasone.		28 weeks