IRB #

STUDY00019913

Title

A Phase 1, Multicenter, Open-Label, Dose Finding Study of CC 99712, A BCMA Antibody-Drug Conjugate, in Subjects with Relapsed and Refractory Multiple Myeloma

Principal Investigator

Eva Medvedova

Study Purpose

The purpose of this study is to determine the safety (any good or bad effects) and to define the appropriate optimal dose of an investigational new drug called CC-99712. The study drug has not been approved by the US Food and Drug Administration for the treatment of multiple myeloma or any other disease, and its use in this study is investigational. You will be given the study drug intravenously (IV) over at least 30 minutes. There are two parts to the study: dose escalation (Part A) and dose expansion (Part B). Participants will be placed into either Part A or Part B depending on when they join the study.

Medical Condition(s)

Relapsed and refractory multiple myeloma

Eligibility Criteria

- Men and women at least 18 years of age with relapsed and refractory multiple myeloma who have disease refractory to their last antimyeloma therapy
- You must have received at least 3 prior MM treatment regimens including a proteasome inhibitor (such as bortezomib), an immunomodulatory agent (such as lenalidomide), and an anti-CD38 antibody (such as daratumumab)

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

You may receive the study drug for up to 2 years as long as you are not experiencing unacceptable side effects, and the investigator determines that you are benefiting from the study drug. When you discontinue from the study drug administration part of the study and stop receiving infusions of the study drug, you will need to come to the clinic for 2 additional visits within 42 days for additional tests and procedures. After that, the investigator will continue to watch you for side effects and follow your condition for a maximum of 2 years.

Minors Included

No

Contact

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

Sponsor

Celgene Corporation

Recruitment End

05/01/2022

Compensation Provided

No


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