drugset / Trial / NCT04392648

A Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

NCT04392648

Non-randomizedSequentialOpen-labelOther

Summary

The purpose of this study is to determine the safety, tolerability, and recommended phase 2 dose (RP2D) of TAK-573 when used with dexamethasone and in combination with bortezomib, pomalidomide, or cyclophosphamide, in participants with RRMM.

Timeline

Start
2020-06-24
Primary completion
2023-11-10
Completion
2023-11-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.3 mg/m2 Subcutaneous
Subject Cyclophosphamide Other / unclassified 300 mg/m2 Oral
Subject Modakafusp alfa Protein / enzyme biologic 0.05 mg/kg Intravenous
Subject Modakafusp alfa Protein / enzyme biologic 0.1 mg/kg Intravenous
Subject Modakafusp alfa Protein / enzyme biologic 0.75 mg/kg Intravenous
Subject Modakafusp alfa Protein / enzyme biologic 1.5 mg/kg Intravenous
Subject Pomalidomide Other / unclassified 4 mg Oral
Background Dexamethasone Small molecule 20 mg Oral
Background Dexamethasone Small molecule 40 mg Oral