Trial Information

A Randomized, Open-Label, Phase 2 Study of CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone Compared With VELCADE-Melphalan-Prednisone for the Treatment of Previously Untreated Multiple Myeloma

The study will be conducted in 2 parts (Part 1 and Part 2) and will consist of screening
period up to 2 weeks; treatment period; maintenance period (CNTO 328) for a maximum of 18
months and follow up period until the study ends. Part 1 is an open-label (all people know
the identity of the intervention), single group safety lead-in part to evaluate the safety
of CNTO 328. Approximately 12 patients will be treated with CNTO 328 in combination with
VMP. If the safety profile of the combination is acceptable, the study will proceed to Part
2. Part 2 is a randomized (the study medication is assigned by chance), open-label, 2-arm
(Arm A: CNTO 328 + VMP; Arm B: VMP alone) study. Approximately 104 patients will be equally
randomized, followed by a maintenance period with CNTO 328 in patients in Arm A who achieve
a partial response (PR) or better. Patients in both parts of the study will be treated up to
a maximum of nine 6-weeks cycles provided there is no evidence of disease progression,
unacceptable toxicity, or withdrawal from treatment. Study medication will be continued for
at least 2 additional cycles after confirmation of complete response, and preferably for the
full 9 cycles of the treatment period. Patients who will be receiving maintenance treatment
after the 12-month effectiveness analysis may continue to receive treatment with CNTO 328
only after careful consideration by the treating physician and on evidence of clinical
benefit and in the absence of unwarranted toxicities. Safety assessments will include
evaluation of adverse events, clinical laboratory tests, eastern cooperative oncology group
performance status, electrocardiogram, vital signs, and physical examination which will be
monitored throughout the study.