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

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00093028
First received: September 29, 2004
Last updated: July 1, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Multiple Myeloma
Drug: CC-5013 (Revlimid™)
Drug: bortezomib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 315
Study Start Date: January 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: CC-5013 (Revlimid™)
    N/A Study Complete
    Drug: bortezomib
    N/A Study Complete
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093028

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

Additional Information:
No publications provided

Responsible Party: Bart Barlogie, MD, PhD, UAMS
ClinicalTrials.gov Identifier: NCT00093028     History of Changes
Other Study ID Numbers: UARK 2003-35
Study First Received: September 29, 2004
Last Updated: July 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
Myeloma
Revlimid
bortezomib
CC-5013
Dexamethasone

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014