CompletedPhase 1/2

Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

United States69 participantsStarted 2013-04

Plain-language summary

Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.

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

. Males and females aged ≥18 years;
. ECOG performance status (PS) 0-2;
. Diagnosis of systemic AL amyloidosis (subjects with non-AL amyloidosis are not eligible);
. Received at least one prior systemic therapy, which may include stem cell transplant, for AL amyloidosis;
. Have adequate organ function;
. Ability to understand and willingness to sign informed consent prior to initiation of any study procedures.

Exclusion criteria

. Secondary or familial amyloidosis;
. Life expectancy of \< 3 months;
. Symptomatic multiple myeloma;
. Hypersensitivities to other monoclonal antibodies;
. Known HIV infection;
. Women who are lactating;

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

Safety and tolerability

Timeframe: 28 day cycles, up to 1 year; beyond 1 year with approval of Sponsor and Investigator

Maximum tolerated dose

Timeframe: 28 day cycles, up to 1 year; beyond 1 year with approval of Sponsor and Investigator

Trial details

NCT IDNCT01707264

SponsorProthena Biosciences Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08-09

View on ClinicalTrials.gov More Primary Amyloidosis trials