Phase 1/2Completed
A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
An Open Label, Dose Escalation, Multicenter Phase 1/2 Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
- Sponsor
- Kyowa Kirin Co., Ltd. (Industry)
- Enrollment
- 95 enrolled
- Conditions
- Multiple Myeloma
- Interventions
- KW-2478; Bortezomib
- Ages
- adults, older adults
- Registry
- NCT01063907, EUCTR2009-016223-56
Full record on ClinicalTrials.gov
From the registry
The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM). The primary objectives: * To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I); * To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II). The secondary objectives: * To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with bortezomib (Phase I only); * To evaluate for preliminary evidence of efficacy (Phase I); * To determine progression free survival (PFS) and duration of response of KW-2478 with bortezomib (Phase II).
Primary outcomes
- To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2).
History
Last registry update
Results first posted
Primary completion
Started
Registered