Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00741377
Status:
COMPLETED
Last Update Posted:
2013-02-18
First Post:
2008-08-22
Brief Title:
A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase IbII Multicenter Dose-determination Study With an Adaptive Randomized Placebo-controlled Double-blind Phase II Using Various Repeated IV Doses of BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients With Prior Skeletal-related Event
Status:
COMPLETED
Status Verified Date:
2013-02
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 has two portions a phase I portion and a phase II portion The purpose of the phase I portion is to assess the maximum-tolerated dose MTD and to characterize dose limiting toxicity DLT of escalating doses of BHQ880 up to a maximum dose of 20 mgkg in combination with standard chemotherapy and zoledronic acid in relapsed or refractory multiple myeloma patients
The phase II portion of the study will also be conducted in relapsed or refractory multiple myeloma patients Patients will be treated with various doses of BHQ880 or placebo in combination standard chemotherapy In the phase II portion of the study zoledronic acid will be added after the first 28 days of therapy with BHQ880 or placebo and standard chemotherapy This will allow any BHQ880-related changes in bone biomarkers to be detected in a zoledronic acid-free environment The purpose of the phase II portion of the study is to determine one or more doses of BHQ880 for further development based on dose-efficacy modeling Efficacy is defined as time to first skeletal-related event and change in bone markers for bone resorption and formation relative to placebo A skeletal-related event is defined as
Pathologic fracture
Spinal cord compression
Requirement for either radiation or surgery to bone due to
Pain
Prevention of imminent fracture
Stabilization of a fracture Biomarker and imaging endpoints will be assessed in both phases of the study The pharmacodynamic effects of BHQ880 will be assessed by measuring biochemical markers of bone formation resorption and metabolism in serum and urine Charges in serum DKK1 levels will be characterized The size and number of lytic bone lesions as measured by bone survey X-ray or MRI will be assessed In addition bone mineral density BMD will be measured by DEXA scan and at selected sites with QCT scans
The phase II portion of the study will also be conducted in relapsed or refractory multiple myeloma patients Patients will be treated with various doses of BHQ880 or placebo in combination standard chemotherapy In the phase II portion of the study zoledronic acid will be added after the first 28 days of therapy with BHQ880 or placebo and standard chemotherapy This will allow any BHQ880-related changes in bone biomarkers to be detected in a zoledronic acid-free environment The purpose of the phase II portion of the study is to determine one or more doses of BHQ880 for further development based on dose-efficacy modeling Efficacy is defined as time to first skeletal-related event and change in bone markers for bone resorption and formation relative to placebo A skeletal-related event is defined as
Pathologic fracture
Spinal cord compression
Requirement for either radiation or surgery to bone due to
Pain
Prevention of imminent fracture
Stabilization of a fracture Biomarker and imaging endpoints will be assessed in both phases of the study The pharmacodynamic effects of BHQ880 will be assessed by measuring biochemical markers of bone formation resorption and metabolism in serum and urine Charges in serum DKK1 levels will be characterized The size and number of lytic bone lesions as measured by bone survey X-ray or MRI will be assessed In addition bone mineral density BMD will be measured by DEXA scan and at selected sites with QCT scans
Detailed Description:
The study was originally planned to have two phases Phase II the dose expansion phase was not conducted
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 |
|---|---|---|---|
| 2008-000411-15 | EUDRACT_NUMBER | None | None |