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NCT01219010 · ClinicalTrials.gov registry record · Phase 1

A Study Evaluating the Effects of Siltuximab on the Heart in Patients With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma

A Phase 1 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT01219010: Completed Phase 1 study, sponsored by Janssen Research & Development.

NCT01219010 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01219010, a Phase 1 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study 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.

Interventions

  • BIOLOGICAL Siltuximab

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2010-10
Est. Completion 2014-03
Phase Phase 1
Janssen Research & Development

593 total trials

What the finished NCT01219010 record still lists

NCT01219010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 1 intervention - of which Siltuximab is the first listed.

NCT01219010 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01219010 about?

NCT01219010 is a clinical study titled "A Study Evaluating the Effects of Siltuximab on the Heart in Patients With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, or Indolent Multiple Myeloma". 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 Mye...

What is the current status of trial NCT01219010?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-10. Estimated completion is 2014-03.

What interventions are being tested in trial NCT01219010?

The interventions under investigation include: Siltuximab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01219010?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01219010's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01219010, the US trial registry maintained by the National Library of Medicine. NCT01219010 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.