Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients

Inclusion Criteria

• •Voluntary written informed consent
• •Male or female subject 18 years of age or older
• •A Karnofsky Performance Status score of ≥50% (Eastern Cooperative Oncology Group Performance Status score ≤2)
• •Subjects must have symptomatic myeloma or asymptomatic myeloma with myeloma-related organ damage
• •Diagnosed Multiple myeloma
• •Subjects must have measurable disease requiring systemic therapy
• •Subjects must not have been treated previously with any systemic therapy for multiple myeloma
• •Two weeks must have elapsed since the date of the last radiotherapy treatment
• •Women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to therapy and repeated within 24 hours before starting study drug. They must commit to continued abstinence from heterosexual intercourse or begin 2 acceptable methods of birth control (1 highly effective method and 1 additional effective method) used at the same time, beginning at least 4 weeks before initiation of Revlimid treatment. Women must also agree to ongoing pregnancy testing
• •Men must agree to not father a child and agree to use a latex condom during therapy and for 4 weeks after the last dose of study drug, even if they have had a successful vasectomy, if their partner is of childbearing potential
• •All subjects must agree to comply with the requirements of the RevAssistSM program