A Phase 2 Study With Panzem in Patients With Relapsed or Plateau Phase Multiple Myeloma

Inclusion criteria

• Have plateau phase (patients who have been previously treated with at least one conventional or high-dose chemotherapy who are currently off all therapy for at least 4 weeks and are considered to have stable disease) or relapsed MM. Patients in plateau phase must have M-protein concentrations that are stable for at least 4 weeks prior to registration.
• Be at least 18 years of age.
• Have monoclonal plasma cells in the marrow.
• have M-protein greater than or equal to 1g/dL in the serum or 200 mg of monoclonal light chain in a 24-hour urine protein electrophoresis.
• Have laboratory data as specified below:

• AST and ALT < 2.5 x upper limit of normal (ULN)
• Alk phos < 5.0 x ULN
• direct bilirubin < 2 x ULN
• Creatinine < 3.0 x ULN
• ANC greater than or equal to 750 cells/mm3
• Platelets > 25,000/mm3
• Hemoglobin greater than or equal to 7.0g/dL
• Have life expectancy of at least 3 months
• Have ECOG performance status of 0, 1, or 2
• Women and men of child bearing potential must agree to use effective barrier contraceptive methods during study.
• Have the ability to understand the reuirements of the study, provide written informed consent, abide to study restrictions, and agree to return for the required assessments.

Exclusion criteria

• Be pregnant or nursing.
• Have any condition that is likely to detrimentally affect regular follow up.
• Have a history of myocardial infarction within the last 3 months, angina pectoris/angina equivalent in the last 3 months, or uncontrolled congestive heart failure.
• Have an active infection
• Have had major surgery within 21 days of starting 2ME2 administration
• Have additional uncontrolled serious medical or psychiatric illness
• have had any active cancer in addition to the MM within the last 5 years (excluding superficial skin cancer)
• Have uncontrolled or untreated active bleeding or thrombotic disorder.