IRB #

STUDY00018117

Title

A Phase 1/2a Open-label, Dose-Escalation Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Patients With Relapsed/Refractory Multiple Myeloma

Principal Investigator

Rebecca Silbermann

Study Purpose

The purpose of the study is to learn more about TAK-079 (the study drug) in people with multiple myeloma. We are hoping to find out if the study drug, when given in combination with approved treatment regimen pomalidomide and dexamethasone (also called PomDex), is safe when given to adults with relapsed/refractory multiple myeloma and whether it causes any side effects. This study will also look at what doses of the study drug, when combined with PomDex, are safe for people to take and what kind of effect it has on multiple myeloma.

Medical Condition(s)

Relapsed/refractory multiple myeloma

Eligibility Criteria

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

Prior therapy should meet all of the following criteria:
- You should be previously treated with at least a proteasome inhibitor (such as carfilzomib), an immunomodulatory drug (such as Revlimid), an alkylating agent (such as cyclophosphamide), and a steroid (such as dexamethasone)
- You should be refractory or intolerant to at least 1 PI and at least 1 IMid
- You should either have received ≥3 prior lines of therapy or should have received at least 2 prior lines of therapy if one of those lines included a combination of PI and IMid
- Previous exposure to an anti-CD38 drug (such as daratumumab), as a single agent or in combination, is allowed but is not required

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

The maximum duration that you may receive the study drug plus PomDex is 18 months unless you are benefitting from its use and your doctor believes that continuing the study drug plus PomDex beyond 18 months is the best option for you. You will have weekly visits for the first two months, then visits every two weeks for the next four months, and then visits once a month after that. Clinic visits usually last 2-3 hours, but may last up to 8 hours on days when you have multiple study-related blood samples collected. After you are no longer receiving the study drug plus PomDex, we may ask to follow your health through the use of clinic visits, medical record review, or follow up phone calls for up to 12 months.

Minors Included

No

Contact

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

Sponsor

Takeda

Recruitment End

01/01/2022

Compensation Provided

No


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