Study Stopped
Study canceled based on results of different study with similar hypothesis, investigational agent, \& patient
A Phase 3 Study of Siltuximab or Placebo in Combination With Velcade and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
A Phase 3, Randomized, Double-blind Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) or Placebo in Combination With VELCADE and Dexamethasone for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma
2 other identifiers
interventional
N/A
14 countries
48
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2011
Shorter than P25 for phase_3 multiple-myeloma
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2010
CompletedFirst Posted
Study publicly available on registry
December 24, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJanuary 28, 2013
January 1, 2013
2.8 years
December 23, 2010
January 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
Event driven, i.e. every 3-4 weeks until progression, death, or end of study (5 years after first patient is dosed)
Secondary Outcomes (5)
Overall survival
Every 3 months until death or end of study (5 years after 1st patient is dosed)
Overall response rate
Every 3 weeks until disease progression or end of study (5 years after 1st patient is dosed)
Siltuximab pharmacokinetic evaluations (Cmin, Cmax) to provide information on the pharmacokinetic profile of siltuximab
Day 1 of Cycles 1, 2, 3, 5, 7, 11, 15, and 19 and during the follow-up period (12 weeks after last dose)
Dexamethasone pharmacokinetic evaluations (Cmin, AUC[t1-t2]) from approx. 30 patients from each treatment arm to provide information on the pharmacokinetic profile of dexamethasone
Pre-dose on Day 1 of Cycles 1, 2 and 3; at Cycle 3 measured 1, 2, 4, 6 and 24 hours after dose
Number of adverse events as a measure of safety and tolerability
Routinely until 30 days after last dose at a minimum, or until end of study
Study Arms (2)
001
EXPERIMENTALSiltuximab Velcade and dexamethasone Given in 21-day treatment cycles Siltuximab 11 mg/kg as 1 hour IV infusion on Day 1 of every cycle Velcade 1.3 mg/m2 IV push on Days 1 4 8 and 11 for Cycles 1-8 and on Days 1 and 8 for Cycles 9 and higher Dexamethasone 20 mg orally on the day of and the day after each Velcade dose
002
OTHERPlacebo Velcade and dexamethasone Given in 21-day treatment cycles Placebo as 1-hour IV infusion on Day 1 of every cycle Velcade 1.3 mg/m2 IV push on Days 1 4 8 and 11 for Cycles 1-8 and on Days 1 and 8 for Cycles 9 and higher Dexamethasone 20 mg orally on the day of and the day after each Velcade dose
Interventions
Siltuximab 11 mg/kg as 1 hour IV infusion on Day 1 of every cycle
Eligibility Criteria
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¿
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Study Sites (48)
Unknown Facility
Iowa City, Iowa, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Willow Grove, Pennsylvania, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
Adelaide, Australia
Unknown Facility
Camperdown, Australia
Unknown Facility
Heidelberg, Australia
Unknown Facility
Parkville, Australia
Unknown Facility
Prahran, Australia
Unknown Facility
Edegem, Belgium
Unknown Facility
Liège, Belgium
Unknown Facility
Turnhout, Belgium
Unknown Facility
Yvoir, Belgium
Unknown Facility
Plovdiv, Bulgaria
Unknown Facility
Sofia, Bulgaria
Unknown Facility
Varna, Bulgaria
Unknown Facility
Toronto, Canada
Unknown Facility
Hradec Králové, Czechia
Unknown Facility
Liberec, Czechia
Unknown Facility
Prague, Czechia
Unknown Facility
Gandhinagar Guiarat, India
Unknown Facility
Apeldoorn, Netherlands
Unknown Facility
Deventer, Netherlands
Unknown Facility
Zwolle, Netherlands
Unknown Facility
Christchurch, New Zealand
Unknown Facility
Grafton, New Zealand
Unknown Facility
Nz 9 Takapuna Auckland, New Zealand
Unknown Facility
Palmerston North, New Zealand
Unknown Facility
Brzozów, Poland
Unknown Facility
Gdansk, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Opole, Poland
Unknown Facility
Wroclaw, Poland
Unknown Facility
Hwasun Gun, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Ankara, Turkey (Türkiye)
Unknown Facility
Bursa, Turkey (Türkiye)
Unknown Facility
Edirne, Turkey (Türkiye)
Unknown Facility
Cherkassy, Ukraine
Unknown Facility
Dnipro, Ukraine
Unknown Facility
Kharkiv, Ukraine
Unknown Facility
Khmelnitskiy, Ukraine
Unknown Facility
Kiev, Ukraine
Unknown Facility
Odesa, Ukraine
Unknown Facility
Simferopol, Ukraine
Unknown Facility
Vinnitsa, Ukraine
Unknown Facility
Nottingham, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2010
First Posted
December 24, 2010
Study Start
July 1, 2011
Primary Completion
April 1, 2014
Study Completion
December 1, 2014
Last Updated
January 28, 2013
Record last verified: 2013-01