NCT01302886

Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma

A Single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With Intravenous BHQ880, a Fully Human, Anti-Dickkopf1 (DKK1) Neutralizing Antibody in Previously Untreated Patients With High-risk, Smoldering Multiple Myeloma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma. BHQ880 will be administered every 28 days in previously untreated patients. Disease assessments will be performed monthly and effects on bone metabolism will be assessed by measurement of serum and urine bone biomarkers, changes in BMD , and QCT with FEA. Additionally, the PK profile of BHQ880 as a single agent and following multiple doses will be obtained.

Conditions

• Smoldering Multiple Myeloma

Interventions

Type	Name	Description
DRUG	BHQ880

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-02-24
• Last updated: 2020-12-17

Locations

13 sites across 3 countries: United States, France, Germany