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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00093028
Recruitment Status : Completed
First Posted : October 1, 2004
Last Update Posted : July 2, 2010
Information provided by:
University of Arkansas

Brief Summary:

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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: CC-5013 (Revlimid™) Drug: bortezomib Phase 3

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 in a lower dose + REVLIMID.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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)
Study Start Date : January 2004
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Intervention Details:
    Drug: CC-5013 (Revlimid™)
    N/A Study Complete
    Drug: bortezomib
    N/A Study Complete

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00093028

United States, Arkansas
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Bart Barlogie, M.D., Ph.D. UAMS Myeloma Institute for Research & Therapy

Additional Information:
Responsible Party: Bart Barlogie, MD, PhD, UAMS Identifier: NCT00093028     History of Changes
Other Study ID Numbers: UARK 2003-35
First Posted: October 1, 2004    Key Record Dates
Last Update Posted: July 2, 2010
Last Verified: July 2010

Keywords provided by University of Arkansas:

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents