Trial Search Results

The PRONTO Study, a Global Phase 2b Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis

The purpose of this study is to evaluate whether NEOD001 is safe and effective in subjects with light chain AL amyloidosis affecting the heart. This study will also evaluate whether NEOD001 improves the function of subjects' organs that have been affected by amyloid deposits.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Prothena Therapeutics Ltd.

Stanford Investigator(s):

Intervention(s):

  • Drug: NEOD001
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   1. Age ≥18 years

   2. Confirmed diagnosis of systemic AL amyloidosis

   3. ≥1 prior systemic plasma cell dyscrasia therapy with at least a partial hematologic
   response

   4. Cardiac involvement

   5. NT-proBNP ≥650

Exclusion Criteria:

   1. Non-AL amyloidosis

   2. Meets the International Myeloma Working Group (IMWG) definition of Multiple Myeloma

   3. NT-proBNP >5000

   4. Received Plasma cell directed chemotherapy within 6 months

   5. Received autologous stem cell transplant (ASCT) within 12 months

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting