Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amylo… (NCT00075621) | Clinical Trial Compass
CompletedPhase 2
Tandem Autologous Stem Cell Transplantation in Treating Patients With Primary Systemic (AL) Amyloidosis
United States62 participantsStarted 2000-08
Plain-language summary
RATIONALE: Autologous stem cell transplantation may be effective treatment for primary systemic (AL) amyloidosis.
PURPOSE: This phase II trial is studying how well tandem (two) autologous stem cell transplantation works in treating patients with primary systemic (AL) amyloidosis.
Who can participate
Age range
18 Years – 65 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:
DISEASE CHARACTERISTICS:
* Histologically confirmed AL amyloidosis, meeting 1 of the following criteria:
* Plasma cell dyscrasia, evidenced by 1 of the following:
* Monoclonal protein in the serum or urine by immunofixation electrophoresis
* Plasmacytosis of the bone marrow with monoclonal staining for kappa or lambda light chain isotype
* Macroglossia with at least 1 other site having biopsy proven amyloidosis and absence of a mutant transthyretin is ruled out
PATIENT CHARACTERISTICS:
Age
* 18 to 65
Performance status
* SWOG 0-2
Life expectancy
* At least 1 year
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* LVEF ≥ 45% by MUGA or echocardiogram
Pulmonary
* DLCO ≥ 50%
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Able to tolerate 2 courses of high-dose therapy
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Prior alkylating agent chemotherapy allowed provided there is no morphologic or cytogenetic evidence of myelodysplastic syndromes
* Prior total cumulative oral melphalan dose \< 300 mg
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 4 weeks since prior cytotoxic therapy and recovered
Exclusion Criteria:
* No senile, secondary, localized, dialysis-related, or familial amyloidosis
* No overt multiple myeloma (e.g., greater tha…
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.