NCT02928029

Study Testing Radium-223 Dichloride in Relapsed Multiple Myeloma

A Phase 1b/2 Trial to Evaluate the Safety and Efficacy of Radium-223 Dichloride (BAY88-8223) in Combination With Bortezomib and Dexamethasone in Early Relapsed Multiple Myeloma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted in 2 parts. The phase 1b part will be an international, phase 1b, open-label, dose-escalation assessment of radium-223 dichloride administered with bortezomib and dexamethasone in subjects with relapsed multiple myeloma. The primary endpoint is to determine the optimal dose of radium-223 dichloride in combination with bortezomib/dexamethasone for the Phase 2 portion of the study. The phase 2 part will be an international, phase 2, double-blind, randomized, placebo-controlled assessment of radium-223 dichloride versus placebo administered with bortezomib and dexamethasone, in subjects with relapsed multiple myeloma. Up to 12 subjects in all dose cohorts combined will be treated in the phase 1b part of the study. Up to approximately 100 subjects will be enrolled in the phase 2 part of the study.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Radium-223 dichloride (Xofigo, BAY88-8223)	Sequential dose escalation in Intravenous (IV) injection
DRUG	Placebo	Matching placebo
DRUG	Bortezomib	Bortezomib is administered subcutaneous (SC) (per Investigator choice ) at 1.3 mg/m2/dose
DRUG	Dexamethasone	Dexamethasone is administered orally at 40 mg

Timeline

• Start date: 2017-02-10
• Primary completion: 2019-03-20
• Completion: 2019-03-20
• First posted: 2016-10-07
• Last updated: 2020-02-26
• Results posted: 2020-02-26

Locations

7 sites across 3 countries: United States, South Korea, Spain

Regulatory

• FDA-regulated drug study