Study of Multiple Myeloma Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2

This is an interventional treatment trial for Multiple Myeloma Read More

Inclusion Criteria:

• History of histologically documented 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:
• Serum M-protein level > 1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis
• Urinary M-protein excretion > 200 mg/24 hrs
• Bone marrow plasmacytosis of > 30percent by bone marrow aspirate and/or biopsy
• Serum Free Light Chains (By the Freelite test) > 10 mg/dL with an abnormal kappa/lambda ration.
• 50percent increase in size of lytic and/or focal lesions or development of new lesions recognized by radiographic studies.
• Performance status of 2 as per SWOG scale, unless PS of 3-4 based solely on bone pain.
• Patients must have a platelet count 50,000/mm3, unless the low platelet count is due to documented (>30 percent) extensive myeloma infiltration of the bone marrow.
• Patients must have adequate renal function defined as serum creatinine < 2.5 mg/dl.
• Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 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 and IRB-approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations
• > 5 x 106 CD34 cells/kg in storage strongly desired, but not mandated

Exclusion Criteria:

• Not previously enrolled on UARK 98-026.
• Has received salvage therapy after coming off UARK 98-026.
• Evidence of POEMS Syndrome..
• Significant neurotoxicity interfering with ADL.
• Platelet count < 50,000/mm3
• 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.
• Truly non-secretory MM (no increase in serum free-light chains) in the absence of bone marrow plasmacytosis and MRI-defined focal lesions with CT-FNA-proven MM
• 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 dose of study drug.
• Breast-feeding women may not participate.