Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) Effects on the QT Interval in Subjects With Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple M

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.

Detailed Summary: This is a research study with an experimental drug called siltuximab (also known as CNTO 328). Currently there are studies with siltuximab, completed or ongoing, in patients with blood cancers such as multiple myeloma and Castleman's disease and with solid tumors such as kidney, ovarian and prostate cancer, to see if siltuximab is safe and to determine what effects it has on these types of cancer. This study is being done in patients with Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM) or Indolent Multiple Myeloma (IMM) to determine if siltuximab has an effect on heart function measured by ECG recordings, and more specifically to determine if siltuximab has any effect on the QT interval. MGUS, SMM and IMM patients usually go on to develop active multiple myeloma which is a type of cancer that affects the blood and bone marrow. The cancer cells in the bone marrow can cause the normal bone marrow cells to breakdown. This can result in low levels of red blood cells (which may make the patient feel tired or fatigued), low levels of white blood cells (which may increase the patient's chances of infections) or low levels of platelets (which may increase risk of bleeding). The cancer cells can cause damage to the normal bone. This can cause bone pain, bone fractures, and can increase the level of calcium in the blood. The cancer cells also make proteins (called M-proteins), which can result in damage to other organs, especially the kidneys. Siltuximab is a chimeric (part mouse and part human) antibody (immunoglobulin that is important for fighting infection). It does this by blocking another small protein called Interleukin 6 (IL-6). The body makes IL-6 naturally, and at normal levels it is important for the inflammatory response. But high levels of IL-6 can help cancer cells grow and interfere with chemotherapy drugs killing cancer cells. Cancer-related sicknesses such as weight loss, bone weakening, and depression have been li
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome: QTc interval [ Time Frame: Screening through Week 10 ]

Original Primary Outcome: QTc interval [ Time Frame: Up to 9 weeks ]

Current Secondary Outcome:

  • Additional safety evaluations [ Time Frame: 6 months and, if eligible, up to 2 years of extended treatment ]
  • Efficacy evaluations [ Time Frame: 6 months and, if eligible, up to 2 years of extended treatment ]
  • Pharmacokinetic and Pharmacodynamic evaluations [ Time Frame: 6 months and, if eligible, up to 2 years of extended treatment ]


Original Secondary Outcome:

  • Number of adverse events as a measure of safety and tolerability [ Time Frame: 6 months and, if eligible, up to 2 years of extended treatment ]
  • Number of patients with M-protein response as a measure of efficacy [ Time Frame: 6 months and, if eligible, up to 2 years of extended treatment ]
  • Determination of siltuximab serum concentrations to provide information on the pharmacokinetic profile [ Time Frame: 6 months and, if eligible, up to 2 years of extended treatment ]
  • Determination of C-Reactive Protein (CRP) levels to characterize the effect of siltuximab on CRP suppression [ Time Frame: 6 months and, if eligible, up to 2 years of extended treatment ]


Information By: Janssen Research & Development, LLC

Dates:
Date Received: September 23, 2010
Date Started: October 2010
Date Completion:
Last Updated: January 16, 2015
Last Verified: January 2015