Ignite Creation Date:
2024-05-05 @ 11:20 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01302886
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2011-01-26
Brief Title:
Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
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
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-022029-13 | EUDRACT_NUMBER | None | None |