Lenalidomide, Dexamethasone and MEDI-551 in Untreated Multiple Myeloma

September 6, 2018 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Sidney Kimmel Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The effect of Lenalidomide, dexamethasone and Medi-551 on multiple myeloma cancer stem cells (CSCs).
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The safety of Medi-551 when combined with Lenalidomide and dexamethasone.
Time Frame: 28 weeks
28 weeks

Other Outcome Measures

Outcome Measure
Time Frame
The pharmacodynamics (reduction in B cells) of this combination
Time Frame: 28 weeks
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

MedImmune LLC

Investigators

  • Principal Investigator: Carol Ann Huff, MD, The Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (Estimate)

May 23, 2013

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1340
  • NA_00081182 (Other Identifier: Johns Hopkins)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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