A Study of Doxil, Vincristine and Decadron (DVd) +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)

November 30, 2016 updated by: Celgene Corporation

A Phase I Study of DVd +/ CC-5013 in Relapsed Refractory Multiple Myeloma (MM)

A Phase I Study of CC-5013 in combination with Doxil, Vincristine and Decadron (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • 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
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Myeloma Program

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form.
  • Age greater than 18 years at the time of signing the informed consent form.
  • Able to adhere to the study visit schedule and other protocol requirements.
  • Diagnosed with active multiple myeloma and be considered to have disease progression after at least 2 cycles of anti-myeloma treatment or have relapsed with progressive disease after treatment.
  • Measurable myeloma paraprotein levels in serum (≥ 0.5g/dL) or urine (≥ 0.2 g excreted in a 24-hour collection sample).
  • Eastern Cooperative Group (ECOG) Performance Status of 0-2. Performance status of 3 and 4 will be allowed if related to bony disease.
  • Bilirubin < 2 x upper limits of normal (ULN).
  • Liver enzymes (ALT or AST) < 3 x ULN.
  • Must have adequate bone marrow function: * Absolute neutrophil count > 1,000 cells/mm3 (1.0 x 109/L) * Platelets ≥ 100,000 cells/mm3 (100 x 109/L) * Hemoglobin ≥ 8 g/dL
  • Must have adequate renal function: creatinine ≤ 2.5 mg/dL.
  • Must have 2-d echocardiogram indicating LVEF ≥ 50% within 42 days prior to first dose of study drug.
  • Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. WCBP must agree to have pregnancy tests every 4 weeks while on study drug.

Exclusion Criteria:

  • Severe infection requiring intravenous antibiotic treatment.
  • Life expectancy of less than 3 months.
  • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years.
  • Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
  • Subjects who have received > 500mg/m2 of doxorubicin alone, or Doxil® alone, or doxorubicin plus Doxil®.
  • Prior treatment with CC-5013.
  • Prior development of ≥ grade 2 (NCI CTC) allergic reaction/hypersensitivity while taking thalidomide.
  • Prior development of a ≥ grade 3 (NCI CTC) rash or any desquamation while taking thalidomide.
  • History of cardiac disease, with New York Heart Association Class II or greater.
  • Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma.
  • Any investigational agent or systemic anti-myeloma therapy within 28 days of the first dose of treatment.
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or lactating females.
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Celgene Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2003

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 13, 2004

First Submitted That Met QC Criteria

September 14, 2004

First Posted (Estimate)

September 15, 2004

Study Record Updates

Last Update Posted (Estimate)

December 1, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-5013-MM-011

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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