Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL) (NCT00981708) | Clinical Trial Compass
CompletedPhase 1/2
Lenalidomide, Dexamethasone and Cyclophosphamide in Amyloidosis (AL)
Greece37 participantsStarted 2008-02
Plain-language summary
The purpose of this study is to determine the safety and activity of the combination of lenalidomide with intermediate dose dexamethasone and cyclophosphamide in patients with primary systemic (AL ) 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.
Inclusion criteria
. Understand and voluntarily sign an informed consent form.
. Age \>=18 years at the time of signing the informed consent form.
. Able to adhere to the study visit schedule and other protocol requirements.
. Confirmed diagnosis of AL amyloidosis (see appendix 3)
. Need for treatment in the judgment of their treating physician
. Evaluable or measurable disease defined by any of the following:
. ECOG Performance Status (PS) 0, 1, 2 or 3
. Laboratory test results within these ranges:
Exclusion criteria
. Patients with symptomatic multiple myeloma with asymptomatic biopsy confirmed AL amyloidosis (Appendix 3)
. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
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
To assess the maximum tolerated dose of lenalidomide and cyclophosphamide and assess the hematologic response rate of the combination of Cyclophosphamide/Dexamethasone plus lenalidomide in patients with AL amyloidosis.
Timeframe: At month 2 for assesment of maximum tolerated dose and monthly for hematologic response
. Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
. Use of any other experimental drug or therapy within 28 days of baseline.
. Known hypersensitivity to thalidomide.
. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.