IRB #

STUDY00017623

Title

A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy with Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Subjects with Relapsed or Refractory Multiple Myeloma

Principal Investigator

Eva Medvedova

Study Purpose

The purpose of this study is to see if the combination of venetoclax, daratumumab, and dexamethasone (with or without bortezomib) is safe and tolerable when dosed in subjects with relapsed (comes back) or refractory (did not get better) multiple myeloma.

Medical Condition(s)

Relapsed or refractory multiple myeloma

Eligibility Criteria

- Men and women at least 18 years of age with relapsed or refractory multiple myeloma

- For Part 1: you must have received at least three prior lines of therapy including a proteasome inhibitor (such as carfilzomib or ixazomib) and an immunomodulatory agent (such as revlimid or pomalidomide), or you are double refractory to a PI and an IMiD

- For Part 2: you must have received prior treatment with at least one, but no more than three, prior lines of therapy for multiple myeloma

- Previous treatment with venetoclax or daratumumab is not allowed

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

You will receive assigned treatment until documented disease progression, unacceptable toxicity, withdrawal of consent, or you meet other criteria for discontinuation per study protocol.

Minors Included

No

Contact

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

Sponsor

AbbVie, Inc.

Recruitment End

10/01/2020

Compensation Provided

No


Go Back