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NCT00741377 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00741377: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT00741377 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00741377, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study 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 mg/kg) 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.
Interventions
- DRUG Zoledronic acid
- DRUG BHQ880
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2009-01 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
What the finished NCT00741377 record still lists
NCT00741377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Zoledronic acid is the first listed.
NCT00741377 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00741377 about?
NCT00741377 is a clinical study titled "A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients". 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 mg/kg) in combination with standard chemo...
What is the current status of trial NCT00741377?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2009-01. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00741377?
The interventions under investigation include: Zoledronic acid (DRUG), BHQ880 (DRUG).
Who is sponsoring clinical trial NCT00741377?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00741377's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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