Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

NCT01861340 | Completed Early Phase 1 DMC

• 2 other identifiers: J1340NA_00081182
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloma

Outcome Measures

Primary Outcomes (1)

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

  16 weeks

Secondary Outcomes (1)

• The safety of Medi-551 when combined with Lenalidomide and dexamethasone.

  28 weeks

Other Outcomes (1)

• The pharmacodynamics (reduction in B cells) of this combination

  28 weeks

Study Arms (1)

Lenalidomide, Dexamethasone, and MEDI-551

EXPERIMENTAL

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.

Drug: Lenalidomide, Dexamethasone, and MEDI-551

Interventions

Lenalidomide, Dexamethasone, and MEDI-551 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.

Lenalidomide, Dexamethasone, and MEDI-551

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• MedImmune LLC: collaborator

Study Sites (1)

The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

Lenalidomide; Dexamethasone; inebilizumab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Carol Ann Huff, MD

  The Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 23, 2013
• Study Start: May 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)