Evaluation of VELCADE Given as Retreatment to Multiple Myeloma Patients for Efficacy, Safety and Tolerability

Inclusion criteria

• Voluntary written informed consent with the understanding that the consent may be w/d by the patient at any time w/o prejudice to future medical care.
• Patient previously diagnosed with Multiple Myeloma (MM).
• Patient previously tolerated 0.7, 1.0, or 1.3 mg/m2/dose of VELCADE alone or therapy combination and had at least a greater/equal 50% reduction in M-Protein upon completion of VELCADE therapy. The DOR prior to VELCADE greater/equal 4 months for the patient population.
• It has been greater/equal 2 months since the patient's last VELCADE dose and the patient meets certain Lab criteria as per protocol.
• Patient has a Karnosfsky performance status greater/equal 60%.
• Patient has a life-expectancy greater than 3 months.
• Patient has laboratory values (defined in protocol) within 14 days before enrollment.

Exclusion criteria

• Patients with a Hx of PD, minimal response, or stable disease (SD)on first exposure to VELCADE.
• Patient has received chemotherapy, radiotherapy, immunotherapy or experimental therapy to treat multiple myeloma since their last dose of VELCADE.
• Patients who achieved a CR or PR but relapsed while on therapy.
• Patient had major surgery w/in 2 wks before enrollment.
• Patient has a Hx of allergic reaction to compounds containing boron or mannitol.
• Patient has peripheral sensory neuropathy of Grade 2 w/pain or greater intensity.
• Patient has cardiac amyloidosis.
• Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or pysychiatric illness.
• Patient is known to be human immunodeficiency virus (HIV)+.
• Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection.
• Patient has an active systemic infection requiring treatment.
• Female patient is pregnant or breast-feeding. Confirmation must be established by a negative serum B-hCG.
• Patient is currently enrolled in another clinical research study.