2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis (NCT00075608) | Clinical Trial Compass
TerminatedPhase 2
2nd Autologous Stem Cell Transplant in Patients With Persistent/Recurrent (AL) Amyloidosis
Stopped: poor accrual
United States12 participantsStarted 2001-08
Plain-language summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Having a stem cell transplant to replace the blood-forming cells destroyed by chemotherapy, allows higher doses of chemotherapy to be given so that more plasma cells are killed. By reducing the number of plasma cells, the disease may progress more slowly.
PURPOSE: This phase II trial is studying how well autologous stem cell transplant works in treating patients with persistent or recurrent primary systemic (AL) amyloidosis.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed AL amyloidosis
* Persistent or recurrent disease after 1 course of prior high-dose chemotherapy
* Previously treated with autologous stem cell transplantation
* Significant initial improvement in organ function after prior high-dose melphalan, defined by at least 1 of the following:
* Complete hematologic remission (e.g., absence of monoclonal spike by immunofixation in serum and urine AND less then 5% plasma cells in bone marrow with no clonal predominance) OR partial hematologic response (e.g., any decrease in serum or urine monoclonal protein OR decrease in bone marrow plasmacytosis)
* Greater than 50% reduction in proteinuria with preservation of creatinine clearance
* Greater than 50% reduction in alkaline phosphatase OR at least 2 cm decrease in liver size by physical exam
* Subjective neurologic improvement, as confirmed by neurologist
* Cardiac stabilization of disease confirmed by echocardiography defined as less than 2 mm increase in mean wall thickness and/or less than 20 g increase in left ventricular mass
* Improvement in performance status\* NOTE: \*This criteria alone does not constitute significant improvement in organ function
* Prior stem cell yield must have been ≥ 2 x 10\^6 CD34+ cells/kg
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* See Disease Characteristics
* No chemotherapy after first transplantation
Endocrine ther…
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.