Ibrutinib With or Without Bortezomib and Dexamethasone in Treating Patients With Relapsed or Refr… (NCT03130348) | Clinical Trial Compass
WithdrawnPhase 2
Ibrutinib With or Without Bortezomib and Dexamethasone in Treating Patients With Relapsed or Refractory Immunoglobulin Light Chain Amyloidosis
Stopped: Study was dropped at site before participation
0Started 2018-03-15
Plain-language summary
This phase II trial studies how well ibrutinib with or without bortezomib and dexamethasone works in treating patients with immunoglobulin light chain amyloidosis that has come back after a period of improvement or that does not respond to treatment. Ibrutinib and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib with or without bortezomib and dexamethasone may work better in treating patients with relapsed or refractory immunoglobulin light chain amyloidosis.
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.
Criteria:
* Measurable disease of AL amyloidosis as defined by at least ONE of the following:
* Serum monoclonal protein \>= 1.0 by protein electrophoresis
* \> 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
* Free light chains (abnormal absolute value, ratio and the dFLC \> 5 mg/dL)
Inclusion Criteria:
* Histological diagnosis of AL amyloidosis as based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens; the type must have been confirmed unequivocally
* Must have had one prior line of systemic therapy for AL; Note: patients who do not achieve at least a PR to frontline therapy in 3 months may be eligible after discussion with study chair
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Absolute neutrophil count (ANC) \>= 1000/mm\^3
* Platelet count \>= 100,000/mm\^3 or \>= 50,000/mm\^3 if bone marrow involvement independent of transfusion support in either situation
* Hemoglobin \>= 8.0 g/dL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) unless due to Gilbert's syndrome or of non-hepatic origin
* Aspartate transaminase (AST) =\< 3 x upper limit of normal (ULN)
* Alanine aminotransferase (ALT) =\< 3 x ULN
* Creatinine =\< 3 mg/dL and creatinine clearance (CrCL) \>= 25 ml/min
* Negative serum pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
* Ability to complete questionnaire(s) by themselves or with ass…
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
Overall hematologic response rate during the first 6 courses for patients treated with ibrutinib, bortezomib, and dexamethasone