Standard of Care Chemotherapy for Light Chain Amyloidosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Light Chain AmyloidosisStandard of Care Chemotherapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new treatment for amyloidosis, a disease where amyloid protein builds up in the body's organs.

Eligible Conditions
  • Light Chain Amyloidosis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Month 9

Month 9
6MWT distance
Physical Component Summary (PCS) score of the Short Form-36, version 2 (SF-36v2)
Physical Component Summary (PCS) score of the The Short Form-36, version 2 (SF-36v2)
Time from the first dose of study drug until the pre-defined number of events (all-cause mortality) have been reached.
Time to all-cause mortality

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Birtamimab plus Standard of Care Chemotherapy
1 of 2
Placebo plus Standard of Care Chemotherapy
1 of 2

Experimental Treatment

Non-Treatment Group

150 Total Participants · 2 Treatment Groups

Primary Treatment: Standard of Care Chemotherapy · Has Placebo Group · Phase 3

Birtamimab plus Standard of Care ChemotherapyExperimental Group · 2 Interventions: Standard of Care Chemotherapy, Birtamimab · Intervention Types: Drug, Drug
Placebo plus Standard of Care ChemotherapyPlaceboComparator Group · 2 Interventions: Standard of Care Chemotherapy, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of Care Chemotherapy
2014
Completed Phase 2
~270

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 9

Who is running the clinical trial?

Prothena Biosciences Ltd.Lead Sponsor
6 Previous Clinical Trials
915 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have your diagnosis of AL amyloidosis with cardiac involvement.
The patient is scheduled to receive a treatment containing bortezomib administered subcutaneously weekly.