An Efficacy and Safety Study of Siltuximab in Participants With Relapsed or Refractory Multiple Myeloma
Completed · Phase 2
Conditions studied: Multiple Myeloma
In brief
The purpose of this study is to evaluate the safety and efficacy of siltuximab in participants with relapsed (the return of a disease or the signs and symptoms of a disease after a period of improvement.) or refractory (cancer that does not respond to treatment) multiple myeloma (a type of cancer that begins in plasma cells \[white blood cells that produce antibodies\]).
Key facts
- Study ID
- NCT00402181
- Run by
- Centocor, Inc.
- People needed
- 53
- Starts
- 2006-10-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2014-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of multiple myeloma with relapsed or refractory disease after failing at least 2 prior lines of therapy
- Prior treatment regimen must have included bortezomib (alone or in combination with other agents)
- Measurable secretory disease defined as either serum monoclonal paraprotein (M- protein) greater than or equal to (>=) 1 gram per deciliter (g/dL) or urine monoclonal (light chain) protein (greater than (>) 200 milligram/24 hours)
- Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to (<=) 2 - Participants of childbearing potential must use adequate birth control measures, female participants of childbearing potential must have a negative serum pregnancy test at screening
You may not qualify if…
- Treatment with systemic cancer therapy (including clarithromycin) or radiotherapy within 30 days before the first dose of study agent - Treatment with nitrosoureas (a group of alkylating agents used as antineoplastic drugs in the chemotherapy) within 42 days before the first dose of study agent
- Major surgery within 30 days before the first dose of study agent or planning to have surgery (except for minor surgical procedures) during the study
- Serious concurrent illness (medical or psychiatric), uncontrolled infection, or significant cardiac disease characterized by significant ischemic coronary disease (an imbalance between myocardial functional requirements and the capacity of the coronary vessels to supply sufficient blood flow) or congestive heart failure (condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body) not under medical control, or any uncontrolled medical condition (for example: uncontrolled diabetes), including the presence of clinical laboratory abnormalities, that places the subject at unacceptable risk by participating in the study or confounds the ability to interpret data from the study
- Known to be seropositive (giving a positive result in a test of blood serum) for Human Immunodeficiency Virus (HIV), or active hepatitis A, B or C infection
Where it is running
- Study site — Duarte, California, United States
- Study site — Norwalk, Connecticut, United States
- Study site — Indianapolis, Indiana, United States
- Study site — Rochester, Minnesota, United States
- Study site — New York, New York, United States
- Study site — Chapel Hill, North Carolina, United States
- Study site — Pittsburgh, Pennsylvania, United States
- Study site — North Charleston, South Carolina, United States
- Study site — Houston, Texas, United States
- Study site — Amsterdam, Netherlands
- Study site — Leiden, Netherlands
- Study site — Rotterdam, Netherlands
- Study site — The Hague, Netherlands
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.