CompletedPhase 2

Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis

United States40 participantsStarted 2007-02

Plain-language summary

The purpose of this study in patients needing treatment for AL amyloidosis is to see how well treatment with IV melphalan works and then, if some clonal plasma cells are still present about 2 to 3 months after melphalan treatment, to see how well treatment with bortezomib and dexamethasone works to reduce the rest of the clonal plasma cell disease.

Who can participate

Age range

18 Years – 70 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.

DISEASE CHARACTERISTICS: * Histologically confirmed amyloidosis * Diagnosed within the past 12 months * Clonal plasma cell disorder, as demonstrated by any of the following: * Presence of M-protein in serum and/or urine by immunofixation and/or serum free light chain assay * Clonal population of plasma cells in the bone marrow based on kappa/lambda staining of a marrow biopsy * Negative genetic testing for hereditary forms of amyloidosis * No amyloid-specific syndrome (e.g., carpal tunnel syndrome or skin purpura) as the only evidence of disease * Vascular amyloidosis only in a bone marrow biopsy specimen or in plasmacytoma is not indicative of systemic amyloidosis * No advanced cardiac amyloidosis * Must have symptomatic involvement of no more than 2 of the following visceral organ systems: * Kidneys * Liver/gastrointestinal * Peripheral/autonomic nervous system * Heart * No persistent pleural effusions * No clinically overt multiple myeloma with \> 30% plasma cells in the bone marrow or lytic bone lesions * Able to undergo autologous stem cell transplantation PATIENT CHARACTERISTICS: * SWOG performance status 0-3 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Bilirubin \< 2.0 mg/dL * Creatinine clearance \< 51 mL/min allowed * LVEF \> 45% by echocardiogram * No New York Heart Association class III-IV congestive heart failure * No history of cardiac syncope * No recurrent symptomatic arrh…

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

Hematologic and Organ Response

Timeframe: 2-3 months post transplant

Trial details

NCT IDNCT00458822

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-03

Results submitted2016-01-04

View on ClinicalTrials.gov More Multiple Myeloma and Plasma Cell Neoplasm trials