Clinical Trial: Daratumumab for the Treatment of Patients With AL Amyloidosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase I-II Trial of Daratumumab for the Treatment of Patients With AL Amyloidosis

Brief Summary: Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression.

Detailed Summary: This Phase I/II study is intended to evaluate the safety and tolerability of infusion of daratumumab in AL amyloidosis, specifically with respect to infusion reactions. In addition, the investigators would like to assess organ response with respect to cardiac biomarkers and proteinuria, as well as hematologic response and time to next treatment. Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression.
Sponsor: Vaishali Sanchorawala

Current Primary Outcome: Assess frequency and severity of side effects and number of patients who respond to treatment [ Time Frame: 3 months ]

number of participants with response and ability to tolerate study treatment


Original Primary Outcome: safety and efficacy [ Time Frame: 3 months ]

number of participants with response and ability to tolerate


Current Secondary Outcome:

  • time to next treatment [ Time Frame: 5 years ]
    number of days from study drug initiation to starting another treatment
  • Assess hematologic response based on blood and urine testing using standard criteria [ Time Frame: 3 months ]
    number of patients with complete or partial response
  • Assess organ responses based on standard criteria included in protocol [ Time Frame: 3 months ]
    number of patients with organ response


Original Secondary Outcome:

  • time to next treatment [ Time Frame: 5 years ]
    number of days from study drug initiation to starting another treatment
  • Hematologic response [ Time Frame: 3 months ]
    number of patients with complete or partial response
  • Organ response [ Time Frame: 3 months ]
    number of patients with organ response


Information By: Boston Medical Center

Dates:
Date Received: June 14, 2016
Date Started: March 20, 2017
Date Completion: August 2020
Last Updated: March 28, 2017
Last Verified: March 2017