Status:
COMPLETED
Study of Bortezomib and Revlimid™ for Patients Relapsing or Progressing on Total Therapy II
Lead Sponsor:
University of Arkansas
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT00093028
Start Date
January 1 2004
End Date
January 1 2006
Last Update
July 2 2010
Active Locations (1)
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1
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205