Study of Bortezomib and Revlimid™ for Patients Relapsing or Progressing on Total Therapy II

July 1, 2010 updated by: University of Arkansas

UARK 2003-35, A Phase III Study of Bortezomib Versus Bortezomib in Two Doses in Combination With Revlimid™ for Patients Relapsing or Progressing on Total Therapy II (UARK 98-026)

The purpose of this study is

  • to find out the effects of treating patients with two new chemotherapy drugs (bortezomib and Revlimid™),
  • to study how many patients' myeloma responds to treatment on this study, and how many patients survive after this treatment,
  • to learn if a patient's genetic makeup before and after treatment can predict which patients will respond to bortezomib and Revlimid™, and to learn more about how the body responds (gene array studies).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two new drugs BORTEZOMIB (Velcade®, PS-341) and REVLIMID (CC-5013) have been shown in recent studies to be effective in patients with advanced multiple myeloma. This study is being done to learn more about the best way to administer these drugs, either alone or in combination. Since it is not known at this time which treatment is the best, participants will be placed by chance in one of the three treatment groups:

  • BORTEZOMIB alone
  • BORTEZOMIB + REVLIMID
  • BORTEZOMIB in a lower dose + REVLIMID.

This chance selection process is called randomization and is often used in research studies.

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Phase 3

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
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences/MIRT

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:

  • History of histologically documented Multiple Myeloma (MM) previously enrolled on UARK 98-026 with relapsed or progressive disease after at least one autologous transplant.
  • Patient has measurable disease in which to capture response, defined as: a. Serum M-protein level > or =1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis b. Urinary M-protein excretion > or =200 mg/24 hrs c. Bone marrow plasmacytosis of > or =30% by bone marrow aspirate and/or biopsy d. Serum Free Light Chains (By the Freelite test) > 2X normal.
  • Performance status of < or = 2 as per Zubrod scale, unless PS of 3 based solely on bone pain.
  • Patients must have a platelet count > or = 50,000/mm3, and an ANC of at least 1,000/μl.
  • Patients must have adequate renal function defined as serum creatinine < or =3.0 mg/dl.
  • Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < or =2 x the upper limit of normal.
  • Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • Male or female adults of at least 18 years of age.
  • Patients must have signed an IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations

Exclusion Criteria:

  • Chemotherapy or radiotherapy received within the previous 2 weeks.
  • Not previously enrolled on UARK 98-026.
  • Has received either CC-5013 or bortezomib therapy after discontinuing from UARK 98-026.
  • Significant neurotoxicity, defined as grade > or = 2 neurotoxicity per NCI Common Toxicity Criteria.
  • Platelet count < 50,000/mm3, or ANC < 1,000/μl
  • POEMS Syndrome
  • Clinically significant hepatic dysfunction as noted by bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis.
  • New York Hospital Association (NYHA) Class III or Class IV heart failure
  • Myocardial infarction within the last 6 months.
  • Non-secretory MM, unless the patient has measurable lesions on CT, MRI and/or PET.
  • Uncontrolled, active infection requiring IV antibiotics.
  • Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
  • Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
  • Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy test at screening, and will be required to use a medically approved contraceptive method. Pregnancy testing will be performed prior to administration of each cycle of study drug.
  • Breast-feeding women may not participate.
  • Known hypersensitivity to thalidomide.

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To find out the effects (good and bad) of treating patients with two new chemotherapy drugs (BORTEZOMIB and REVLIMID).
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To learn if a patient's genetic makeup before and after treatment can predict which patients will respond to BORTEZOMIB and REVLIMID, and to learn more about how the body responds (gene array studies).
Time Frame: 24 months
24 months

Collaborators and Investigators

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

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Bart Barlogie, M.D., Ph.D., UAMS Myeloma Institute for Research & Therapy

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.

Helpful Links

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

January 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

September 29, 2004

First Submitted That Met QC Criteria

September 30, 2004

First Posted (Estimate)

October 1, 2004

Study Record Updates

Last Update Posted (Estimate)

July 2, 2010

Last Update Submitted That Met QC Criteria

July 1, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UARK 2003-35

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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