Study on the Safety and Effectiveness of VELCADE® in the Treatment of Graft-Versus-Host Disease (NCT00408928) | Clinical Trial Compass
CompletedPhase 2
Study on the Safety and Effectiveness of VELCADE® 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 VELCADE® 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. VELCADE® is a drug that inhibits certain immune reactions that happen when lymphocytes encounter foreign substances. We are doing this research to determine if VELCADE® may be useful in treating GVHD.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must have undergone an allogeneic HSCT
. Clinical or histological evidence of AGVHD
. Has been treated with a minimum of 2mg/kg of methylprednisolone per day or equivalent dose of steroids and either one of the following:
. Has had a minimum of 3 days of steroids including the day of assignment and has progressive disease.
. Has had a minimum of 7 days of steroids including the day of assignment and has had no response.
. AGVHD progresses at anytime when steroids are tapered to less than 2mg/kg/day of methylprednisolone or its equivalent.
. Performance status ECOG 0-2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Response to Bortezomib (VELCADE®)
Timeframe: Through 30 days post-treatment
Trial details
NCT IDNCT00408928
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
. Patients must be willing to use contraception if they have childbearing potential
Exclusion criteria
. Performance status of ECOG \>2.
. \>Grade3 peripheral neuropathy at the time of enrollment
. Patient has a creatinine clearance (calculated or measured) of \<30mL/min at the time of enrollment.
. 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.
. Patient has hypersensitivity to bortezomib, boron or mannitol.
. Female subject is pregnant or breast-feeding.
. Patient has received other investigational drug within 14 days prior to enrollment.
. Serious medical or psychiatric illness likely to interfere with participation in this clinical study or to obtain informed consent.