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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Treatments: Bortezomib; Lenalidomide; Thalidomide

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.