NCT01219010

Brief Summary

The purpose of this study is to determine if siltuximab has an effect on the heart function measured by ECG recordings and more specifically to determine if siltuximab has an effect on the QT interval in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM). The study will also look to see if siltuximab may be useful in treating patients with MGUS, SMM or IMM.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2010

Typical duration for phase_1

Geographic Reach
3 countries

8 active sites

Status
completed

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

September 23, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

September 23, 2010

Last Update Submit

January 16, 2015

Conditions

Monoclonal Gammopathy of Undetermined SignificanceMultiple MyelomaPlasma Cell Neoplasm

Keywords

Monoclonal Gammopathy of Undetermined SignificanceSmoldering Multiple MyelomaIndolent Multiple MyelomaQTSiltuximabCNTO 328IL-6Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

  • QTc interval

    Screening through Week 10

Secondary Outcomes (3)

  • Additional safety evaluations

    6 months and, if eligible, up to 2 years of extended treatment

  • Efficacy evaluations

    6 months and, if eligible, up to 2 years of extended treatment

  • Pharmacokinetic and Pharmacodynamic evaluations

    6 months and, if eligible, up to 2 years of extended treatment

Study Arms (1)

001

EXPERIMENTAL

Siltuximab 15mg/kg IV infusion every 3 weeks for 4 cycles. If applicable extended dosing of 15 mg/kg IV infusion every 4 weeks for up to 2 years.

Biological: Siltuximab

Interventions

SiltuximabBIOLOGICAL

15mg/kg IV infusion every 3 weeks for 4 cycles. If applicable extended dosing of 15 mg/kg IV infusion every 4 weeks for up to 2 years.

001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of MGUS (measurable serum M-protein \< 3 g/dL AND clonal bone marrow plasma cells \< 10% without any end organ damage), SMM (measurable serum M-protein = 3 g/dL OR clonal bone marrow plasma cells = 10% without any end organ damage) or IMM (measurable serum M-protein = 3 g/dL OR clonal bone marrow plasma cells = 10% and = 3 lytic bone lesions but no other end organ damage)
  • Qualifying ECG results that will be checked by a central laboratory
  • Negative urine drug screen for substances of abuse
  • Qualifying hematology and chemistry laboratory results.

You may not qualify if:

  • Diagnosis of symptomatic multiple myeloma
  • Prior exposure to approved or investigational myeloma treatments
  • Prior exposure to agents targeting IL-6 or the IL-6 receptor
  • Significant cardiac disease
  • Skin condition likely to interfere with ECG electrode placement, breast implant, or thoracic surgery
  • Received medications known to affect the QT interval
  • Vaccination with live, attenuated vaccines within 4 weeks
  • Major surgery or radiation within 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Izhevsk, Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Nizhny Novgorod, Russia

Location

Related Links

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined SignificanceMultiple MyelomaNeoplasms, Plasma CellSmoldering Multiple Myeloma

Interventions

siltuximab

Condition Hierarchy (Ancestors)

HypergammaglobulinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesParaproteinemiasImmunoproliferative DisordersImmune System DiseasesNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersLymphoproliferative DisordersPrecancerous Conditions

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2010

First Posted

October 13, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2012

Study Completion

March 1, 2014

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

RU(3)BE(2)US(3)