Last updated on September 2018

A Study to Investigate the Safety Tolerability Efficacy Pharmacokinetics and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)

Brief description of study

The purpose of this study is to assess the safety, tolerability, maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) in Phase 1 of the study and to provide a preliminary evaluation of the clinical activity of TAK-079 monotherapy in participants with r/r MM in Phase 2a of the study.

Detailed Study Description

The drug being tested in this study is called TAK-079. TAK-079 is being tested to treat people who have r/r MM. This study will assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of TAK-079 monotherapy and will provide a preliminary assessment of its activity against MM. The study is designed to consist of 2 phases: Phase 1 and Phase 2a.

The study will enroll approximately 42 participants. The study population of Phase 1 will consist of approximately 24 participants. Participants in Phase 1 will be assigned to TAK-079 and dose-escalation will range from 45 mg to 1800 mg.

In Phase 1, participants will receive premedications 1 to 3 hours prior to the administration of TAK-079 on each dosing day, as follows:

  • Dexamethasone 20 mg
  • Acetaminophen 650 to 1000 mg
  • Diphenhydramine 25 to 50 mg
  • Montelukast 10 mg

The study population of Phase 2a will consist of approximately 18 participants. Dose and premedications for Phase 2a will be based upon review of the available safety, efficacy, pharmacokinetic, and pharmacodynamic data from the preceding cohorts of Phase 1.

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 48 months (4 years). In Phase 1, participants who stop treatment for any other reason other than PD will continue to have progression-free survival (PFS) follow-up at the site every 4 weeks from the last dose of study drug up to 12 months or until PD, death, loss to follow-up, consent withdrawal or study termination. Participants will be followed 30 days after last dose of study drug or until the start of subsequent alternative anti-cancer therapy, whichever occurs first, for a follow up assessment.

Clinical Study Identifier: NCT03439280

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Recruitment Status: Open

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