Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) (NCT02102594) | Clinical Trial Compass
TerminatedPhase 2
Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)
Stopped: recruitment difficulties
Germany11 participantsStarted 2014-10
Plain-language summary
The aim of this pilot study is to investigate the application of proteasome inhibitor Bortezomib (Velcade®, approved for therapy of multiple myeloma) in patients with therapy-refractory antibody-mediated autoimmune diseases. The investigators hypothesis is that the proteasome inhibition will lead to reduced antibody titers and improved clinical outcome.
Who can participate
Age range
18 Years – 75 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.
(main) Inclusion Criteria:
* age 18 - 75 years at screening
* ability to give written consent, informed written consent
* negative pregnancy test at screening
* therapy-refractory Myasthenia Gravis (generalized) or Systemic Lupus Erythematosus or Rheumatoid Arthritis
(main) Exclusion Criteria:
* Belimumab therapy within the last 6 months
* B-cell-depletion therapy within the last 9 months
* heart or kidney insufficiency
* known intolerability to Bortezomib
* participation in another interventional trial within the last 3 months
* liver cirrhosis
* preexistent sensory or motor polyneuropathy ≥ degree 2 (NCI CTC AE criteria), within 14 days before screening
* hints on clinically apparent herpes zoster reactivation
* active systemic infection, or viral infection (CMV, EBV) within last 6 month before screening
* serologically active hepatitis B and /or C, known HIV infection
* tumor disease currently or within last 5 years
* clinically relevant liver, kidney or bone marrow function disorder
* pregnancy or lactation
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
change in disease specific antibody titers after application of Bortezomib
Timeframe: 6 months after end of therapy (6 weeks) compared to baseline (before therapy)