IRB #

STUDY00020276

Title

An Open-Label, Multicenter Phase 1b Study Investigating the Safety of TAK-079 in Combination With Backbone Regimens for the Treatment of Patients with Newly Diagnosed Multiple Myeloma and for Whom Stem Cell Transplantation Is Not Planned as Initial Therapy

Principal Investigator

Rebecca Silbermann

Study Purpose

The purpose of the study is to learn more about an investigational drug called TAK-079 (the study drug) for use in participants with multiple myeloma. We are hoping to find out the best dose of the study drug when given to you in combination with a standard of care regimen (also called a backbone treatment regimen). There will be two study groups (arms):
- Arm A: the study drug, lenalidomide and dexamethasone
- Arm B: the study drug, bortezomib, lenalidomide and dexamethasone

Medical Condition(s)

Newly diagnosed multiple myeloma

Eligibility Criteria

- You must be at least 18 years of age and have previously untreated multiple myeloma that is now requiring treatment according to your cancer doctor
- You are not expected to undergo a stem cell transplant as initial therapy for your multiple myeloma

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study medications for up to 2 years, unless your disease worsens or you experience unacceptable side effects. After your last dose of study drug, the investigator will continue to watch you for side effects and follow your condition for up to 12 months.

Minors Included

No

Contact

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

Sponsor

Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited)

Recruitment End

08/01/2022

Compensation Provided

No


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