Last updated on April 2019

A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis


Brief description of study

The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

Detailed Study Description

Participant involved in study for approx. 8 years duration includes Screening Phase (complete clinical evaluation will be done), Treatment Phase (monitoring of adverse events (AEs), laboratory abnormalities and clinical response), Post-Treatment Observation Phase (disease evaluations will be done) and a Long-term Follow-up Phase (Subsequent anticancer treatment, response to subsequent treatment, date of progression and survival status will be obtained every 16 weeks).The primary hypothesis is that daratumumab in combination with CyBorD will improve the overall complete hematological response rate compared to CyBorD alone in AL amyloidosis participants. Safety will be assessed by AEs, laboratory test results, electrocardiogram, vital sign measurements, physical examination, and Eastern Cooperative Oncology Group (ECOG) performance status.

Clinical Study Identifier: NCT03201965

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Mayo Clinic Arizona

Phoenix, AZ United States
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City of Hope

Duarte, CA United States
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Stanford University

Stanford, CA United States
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University of Colorado

Aurora, CO United States
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Mayo Clinic

Jacksonville, FL United States
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Tufts Medical Center

Boston, MA United States
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Mayo Clinic Rochester

Rochester, MN United States
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Memorial Sloan Kettering

New York, NY United States
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Levine Cancer Institute

Charlotte, NC United States
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Cleveland Clinic

Cleveland, OH United States
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The Ohio State University

Columbus, OH United States
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Huntsman Cancer Institute

Salt Lake City, UT United States
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Box Hill Hospital

Box Hill, Australia
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Westmead Hospital

Westmead, Australia
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UZ Gent

Gent, Belgium
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Az Groeninge

Kortrijk, Belgium
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Haga ziekenhuis

Den Haag, Netherlands
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UMCG

Groningen, Netherlands
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Erasmus MC

Rotterdam, Netherlands
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UMC Utrecht

Utrecht, Netherlands
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Maxima Medisch Centrum

Veldhoven, Netherlands
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CEHON

Salvador, Brazil
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Swedish Cancer Institute

Seattle, WA United States
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CHU Dijon

Dijon, France
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Chu Hotel Dieu

Nantes Cedex 01, France
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Hopital Saint-Louis

Paris Cedex 10, France
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CHU Rangueil

Toulouse, France
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CHU Bretonneau

Tours Cedex, France
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CHU de Nancy_ H pital Brabois

Vandoeuvre Les Nancy, France
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Asan Medical Center

Seoul, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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University of Maryland

Baltimore, MD United States
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IAMSPE

São Paulo, Brazil
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HCFMUSP

São Paulo, Brazil
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Centre hospitalier Lyon-Sud

Pierre - Bénite Cedex, France
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Hosp. Univ. de Canarias

San Cristóbal De La Laguna, Spain
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Recruitment Status: Open


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