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A Study to Evaluate Daratumumab in Newly Diagnosed Systemic AL Amyloidosis


Title A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis
Therapeutic Area Amyloidosis
Principal Investigator Raymond Comenzo, MD
Min Age 18 Years
Gender All
Contact George Mensing
617-636-2683
More Information https://clinicaltrials.gov/ct2/show/NCT03201965

Overview

The experimental drug used in this study is called daratumumab, or JNJ-54767414, a CD38 monoclonal antibody. The purpose of this study is to see if daratumumab when given with three other drugs [cyclophosphamide, bortezomib (VELCADE®) and dexamethasone] is useful for treating participants with Amyloid light chain Amyloidosis (also known as AL Amyloidosis). The study will look at what happens (both good and bad) when daratumumab is given with these three drugs compared to just giving those three drugs alone. The safety of daratumumab when given with cyclophosphamide, bortezomib and dexamethasone (CyBorD) will also be studied.

Study Details

Inclusion Criteria

  • Diagnosis of amyloidosis
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2

Exclusion Criteria

  • Prior therapy for AL amyloidosis or multiple myeloma
  • Evidence of significant cardiovascular conditions

Study Requirements

Group A: Cyclophosphamide, bortezomib (VELCADE®) and dexamethasone (CyBorD)
  • Cyclophosphamide: taken weekly by mouth or through a vein (IV) for 6 cycles
  • Bortezomib: taken weekly as an injection under the skin (SC) for 6 cycles
  • Dexamethasone: taken weekly by mouth or through a vein (IV) for 6 cycles
Group B: Daratumumab plus cyclophosphamide, bortezomib (VELCADE®) and dexamethasone (CyBorD)
  • Daratumumab: given according to the following schedule as an injection under the skin (SC):
    • Cycles 1 and 2: given every week
    • Cycle 3 to 6: given every other week
    • Cycles 7 and beyond: given every 4 weeks for a maximum of 2 years
  • Cyclophosphamide: taken weekly by mouth or through a vein (IV) for 6 cycles
  • Bortezomib: taken as an injection under the skin (SC) weekly for 6 cycles
  • Dexamethasone: taken by mouth or through a vein (IV) weekly for 6 cycles
Participants will also be having physical exams, ECGs, an ECHO, skeletal survey, blood draws, questionnaires and other proceduers as required per protocol.