A Phase II Study of Siltuximab in Patients with High-Risk Smoldering Multiple Myeloma

Protocol
12-068
Full Title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) in Subjects with High-Risk Smoldering Multiple Myeloma
Phase
II
Disease Status
Newly Diagnosed
Purpose

Patients with smoldering multiple myeloma have no symptoms but are at risk of having their disease progress to symptomatic multiple myeloma. In this study, researchers are evaluating the safety and effectiveness of an investigational drug called siltuximab to see if it can prevent or delay the progression of the disease to symptomatic multiple myeloma.

Siltuximab is a monoclonal antibody that inhibits interleukin-6, a protein which is normally produced in the body but which, at high levels, can cause myeloma cells to grow and cause symptomatic multiple myeloma. It is given intravenously.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have been diagnosed with high-risk smoldering multiple myeloma within four years of entering the study.
  • Patients may not have received prior treatment for multiple myeloma.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please call the Myeloma Referral Line at 646-497-9062.

Disease(s)
Hematology: Multiple Myeloma
Locations
Related Diseases