A Phase 1 Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Refractory or Relapsed Multiple Myeloma

Inclusion Criteria:

- Confirmed diagnosis of multiple myeloma (either secretory or nonsecretory disease)

- Relapsed or refractory disease

- At least two prior treatment regimens

- 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%

Exclusion Criteria:

- Prior allogeneic bone marrow transplant, including syngeneic transplant

- Known intracranial disease or epidural disease

- 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

- Symptomatic hyperviscosity syndrome

- Any other cancer therapy within 3 weeks prior to study, except for mitomycin C,
nitrosoureas, or high-dose chemotherapy with stem cell support 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