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NCT00116961 · ClinicalTrials.gov registry record · Phase 2
Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00116961 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 40 participants.
The verdict
NCT00116961, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options. One of the new medications in multiple myeloma is Velcade. Preliminary results from a study using a combination of Velcade with Doxil have shown high response rates (disease reduction). Preliminary results also show that an addition of dexamethasone to Velcade in patients not responding to Velcade alone showed improved response rates. This study involves treatment with a new combination of three standard medications: Velcade, Doxil, and dexamethasone (VDd combination). The proposed combination of all three drugs may improve efficacy and response. Velcade is approved by the Food and Drug Administration (FDA) for treatment in multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Velcade is still currently under investigation for other indications. Doxil is not approved for use in multiple myeloma but is an approved drug for use in patients with some other cancers. Several published clinical trials provide evidence that Doxil is an active agent in multiple myeloma and it is used in treatment combinations for multiple myeloma in general practice. Dexamethasone is a standard therapy for multiple myeloma, but is not approved by the FDA for that use. The combination of all three drugs is experimental (not FDA approved). The goals of this study are to determine if this new combination therapy with Velcade, Doxil and dexamethasone is an effective treatment and also to determine the side effects that occur when this combination treatment is given.
Interventions
- DRUG Dexamethasone
- DRUG Doxil
- DRUG Velcade
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-06 |
| Est. Completion | 2007-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00116961
The ClinicalTrials.gov registry entry for NCT00116961 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT00116961 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00116961 about?
NCT00116961 is a clinical study titled "Velcade, Doxil, and Dexamethasone (VDd) as First Line Therapy for Multiple Myeloma". This is a research study for patients with newly diagnosed multiple myeloma. Multiple myeloma remains a non-curable disease however, newer medications and their combinations appear to provide higher response rates and higher complete response rates than current treatment options. One of the new medi...
What is the current status of trial NCT00116961?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2005-06. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00116961?
The interventions under investigation include: Dexamethasone (DRUG), Doxil (DRUG), Velcade (DRUG).
Who is sponsoring clinical trial NCT00116961?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
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