CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0113 (clinicaltrials.gov NCT No: NCT00911859)
Title: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
Principal Investigator:Robert Orlowski
Treatment Agent:Bortezomib; CNTO 328; Melphalan; Prednisone
Study Status:Terminated
Study Description:The goal of this clinical research study is to learn if the combination of
Siltuximab (CNTO 328) and VMP (a combination of the drugs Velcade [bortezomib],
melphalan, and prednisone) can more effectively control MM than VMP alone. The
safety of this combination will also be studied.

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Disease Group:Myeloma
Phase of Study:Phase II
Treatment Agents:Bortezomib
CNTO 328
Melphalan
Prednisone
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:No hospitalization required.
Supported By:Janssen Research & Development
Return Visit:Cycles 1-4
Velcade - Days 1,4,8,11,22,25,29,32
MP-Days 1-4
CNTO 328 - Days 1, 22

Cycles 5-9
Velcade - Days 1, 8, 22, 29
MP - Days 1-4
CNTO 328 - Days 1, 22
Home Care:No home care.


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Physician Name:Robert Orlowski
Dept:Lymphoma/Myeloma
For Clinical Trial Enrollment:713-792-2860
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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