NCT01337752

Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency

A Double-blind, Placebo-controlled, Randomized Phase 2 Study of BHQ880, an Anti-Dickkopf1 (DKK1) Monoclonal Antibody (mAb), in Patients With Untreated Multiple Myeloma and Renal Insufficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study.

Conditions

• Multiple Myeloma
• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	BHQ880
DRUG	BHQ880 Placebo	Intravenous infusion
DRUG	bortezomib	intravenous injection
DRUG	dexamethasone	Oral

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-04-19
• Last updated: 2020-12-17

Locations

8 sites across 3 countries: United States, Spain, United Kingdom