A Study To Evaluate The Effectiveness And Safety Of Birtamimab In Mayo Stage IV Patients With AL Amyloidosis

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of birtamimab plus standard of care compared to placebo plus standard of care in patients with AL amyloidosis in Mayo Stage IV.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Aged ≥ 18 years.
  • Newly diagnosed and AL amyloidosis treatment-naïve with cardiac involvement.
  • Confirmed diagnosis of AL amyloidosis.
  • Confirmed Mayo Stage IV AL Amyloidosis as defined by -NT-proBNP ≥ 1800 pg/mL and -Troponin-T > 0.03 ng/mL and -dFLC ≥ 18 mg/dL.
  • Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly.

Exclusion Criteria:

  • Non-AL amyloidosis.
  • NT-proBNP > 8500 pg/mL.
  • Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma.
  • Subject is eligible for and plans to undergo ASCT or organ transplant during the study.
  • Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia, within 6 months prior to the Month 1-Day 1 Visit.
  • Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area < 1.0 cm^2) or severe congenital heart disease.
  • ECG evidence of acute ischemia or active conduction system abnormalities.
  • Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day 1.
  • Prior radiotherapy within 4 weeks of Month 1-Day 1.
  • Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11- 1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or other investigational treatment directed at amyloid.
  • Waldenström's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Morie Gertz, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available