A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis (IMPACT-AL)

Contact:

NCT Number:

Protocol:

AAAV8827

Study Status:

Active/Enrolling

Population:

Adult

Phase:

II

The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in Immunoglobulin Light Chain (AL) amyloidosis. Specifically, the study will look at whether this treatment can lower harmful proteins (light chains) in the blood that causes organ damage in AL amyloidosis. The goal is to stop further organ damage, facilitate organ recovery over the long run, and help patients live longer. Of note, daratumumab is currently Food and Drug Administration (FDA)-approved for the treatment of newly diagnosed AL amyloidosis. Teclistamab is not FDA-approved for amyloidosis currently. However, it has been FDA approved for use in relapsed/refractory multiple myeloma. The combination of daratumumab and teclistamab is investigational but has been approved for use in research.

Are you Eligible? (Inclusion Criteria)

  • Age greater than 18 years old -ECOG performance status of 0, 1, or 2 -Able to comply with the study protocol (as per investigator's judgement)

Specialty Area(s)

Multiple Myeloma/Amyloidosis, Immunotherapy

Principal Investigator

Profile Headshot
  • Director, Multiple Myeloma and Amyloidosis Program

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032
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