IRB #

STUDY00017199

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

Principal Investigator

Eva Medvedova

Study Purpose

The purpose of this study is to see if daratumumab when given with three other drugs (cyclophosphamide, bortezomib and dexamethasone) is useful for treating patients 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.

Medical Condition(s)

AL Amyloidosis

Eligibility Criteria

- Men and women who are at least 18 years of age
- Diagnosed with amyloid light chain amyloidosis (AL Amyloidosis)
- No prior therapy for your AL Amyloidosis
- No previous or current diagnosis of symptomatic multiple myeloma

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Up to 6 years total. You will be on study medications for a maximum of 2 years, followed by long-term follow-up for as long as 4 years.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Janssen Research & Development, LLC

Recruitment End

01/01/2022

Compensation Provided

No


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