All > Al Amyloidosis > Knoxville

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

Similar Trials

1
Florbetaben
1
Isatuximab
1
Dexamethasone

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

Similar Trials

1
Florbetaben
1
Isatuximab
1
Dexamethasone

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.
References

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top