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)
- History of histologically documented Multiple Myeloma (MM) previously enrolled on
UARK 98-026 with relapsed or progressive disease after at least one autologous
- 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
- Patients must have a platelet count > or = 50,000/mm3, and an ANC of at least
- Patients must have adequate renal function defined as serum creatinine < or =3.0
- 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
- 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
- Significant neurotoxicity, defined as grade > or = 2 neurotoxicity per NCI Common
- 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
- 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.