Safety and Dose Study of GRN163L and Velcade to Treat Patients With Refractory or Relapsed Myeloma

Inclusion Criteria:

Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease)
Relapsed or refractory disease
ECOG performance status 0-2
Adequate hepatic/renal function and platelet count
If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50%
Fully recovered from any previous cancer treatments and/or major surgery

Exclusion Criteria:

Prior allogeneic bone marrow transplant, including syngeneic transplant
Bone marrow transplant within 12 weeks prior to study
Known intracranial disease or epidural disease
Inability to tolerate Velcade
Inability to tolerate Decadron
Prior malignancy (within the last 3 years)
Clinically significant cardiovascular disease or condition
Active or chronically recurrent bleeding (eg, active peptic ulcer disease
Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN
Clinically relevant active infection
Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease
Any other cancer therapy within 4 weeks prior to study, with nitrosourea within 6 weeks prior to study
Investigational therapy within 4 weeks prior to study
Anti-platelet therapy within 2 weeks prior to study, other than low dose aspirin prophylaxis therapy and low dose heparin administration for management of IV access devices
Radiation therapy within 4 weeks prior to study
Major surgery within 4 weeks prior to study
Active autoimmune disease requiring immunosuppressive therapy
Known positive serology for HIV