Study on the Safety and Effectiveness of VELCADEĀ® in the Treatment of Graft-Versus-Host Disease (NCT00408928) | Clinical Trial Compass
CompletedPhase 2
Study on the Safety and Effectiveness of VELCADEĀ® in the Treatment of Graft-Versus-Host Disease
United States11 participantsStarted 2005-11
Plain-language summary
The purpose of this research study is to test the safety and effectiveness of VELCADEĀ® in the treatment of acute graft-versus-host disease (GVHD) that has not responded to steroids or has worsened when the steroid dose was decreased. VELCADEĀ® is a drug that inhibits certain immune reactions that happen when lymphocytes encounter foreign substances. We are doing this research to determine if VELCADEĀ® may be useful in treating GVHD.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Patients must have undergone an allogeneic HSCT
ā. Clinical or histological evidence of AGVHD
ā. Has been treated with a minimum of 2mg/kg of methylprednisolone per day or equivalent dose of steroids and either one of the following:
ā. Has had a minimum of 3 days of steroids including the day of assignment and has progressive disease.
ā. Has had a minimum of 7 days of steroids including the day of assignment and has had no response.
ā. AGVHD progresses at anytime when steroids are tapered to less than 2mg/kg/day of methylprednisolone or its equivalent.
ā. Performance status ECOG 0-2
ā. Patients must be willing to use contraception if they have childbearing potential
Exclusion criteria
ā. Performance status of ECOG \>2.
ā. \>Grade3 peripheral neuropathy at the time of enrollment
ā. Patient has a creatinine clearance (calculated or measured) of \<30mL/min at the time of enrollment.
ā. Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry , any ECG abnormality at Screening has to be documented by the investigator/co-investigator as not medically relevant.
What they're measuring
1
Response to Bortezomib (VELCADEĀ®)
Timeframe: Through 30 days post-treatment
Trial details
NCT IDNCT00408928
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University