A Phase 3 Study of Siltuximab or Placebo in Combination With Velcade and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to determine if there is an improvement in progression-free survival (length of time during and after treatment in which a patient is living with a disease that does not get worse) when siltuximab is added to VELCADE and dexamethasone in subjects with relapsed or refractory multiple myeloma.

Key facts

Study ID

NCT01266811

Run by

Centocor, Inc.

People needed

0

Starts

2011-07-01

Expected to finish

2014-12-01

Last updated by the study team

2013-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of multiple myeloma requiring treatment
• Measurable secretory disease, defined as either serum M-protein >=1 g/dL or urine M-protein (light chain) >=¿200 mg/24 hours
• Must have received 1 to 3 lines of prior treatment for multiple myeloma
• Must have achieved a response (Minimal Response or better) to at least 1 prior line of treatment
• Must have progressed on or been refractory (defined as < Minimal Response or disease progression within 60 days of last dose) to the most recent line of treatment
• Must not be refractory to any previous line of treatment that included a proteasome inhibitor
• Qualifying hematology and chemistry laboratory results.

You may not qualify if…

• Diagnosis of primary amyloidosis, plasma cell leukemia, or other conditions in which a paraprotein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
• Grade 1 peripheral neuropathy with pain or Grade 2 or higher peripheral neuropathy
• Allogeneic bone marrow transplantation within 28 days
• Bone marrow transplant planned within 12 months after study start
• Chemotherapy or radiation therapy within 21 days
• Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B surface antigen positivity
• Major surgery within 21 days before or planned during the study
• Subjects who the investigator believes would not tolerate starting doses of VELCADE or dexamethasone
• Significant cardiac disease or myocardial infarction within 6 months
• Vaccination with live attenuated vaccines within 4 weeks
• Prior exposure to agents targeting IL-6 or the IL-6 receptor
• Received any investigational agent within 30 days¿

Where it is running

• Study site — Iowa City, Iowa, United States
• Study site — Boston, Massachusetts, United States
• Study site — Toledo, Ohio, United States
• Study site — Willow Grove, Pennsylvania, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Adelaide, Australia
• Study site — Camperdown, Australia
• Study site — Heidelberg, Australia
• Study site — Parkville, Australia
• Study site — Prahran, Australia
• Study site — Edegem, Belgium
• Study site — Liège, Belgium
• Study site — Turnhout, Belgium
• Study site — Yvoir, Belgium
• Study site — Plovdiv, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Varna, Bulgaria
• Study site — Toronto, Canada
• Study site — Hradec Králové, Czechia
• Study site — Liberec, Czechia
• Study site — Prague, Czechia
• Study site — Gandhinagar Guiarat, India
• Study site — Apeldoorn, Netherlands
• Study site — Deventer, Netherlands
• Study site — Zwolle, Netherlands

Full record on ClinicalTrials.gov

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