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NCT00849251 · ClinicalTrials.gov registry record · Phase 1
Pegylated Liposomal Doxorubicin Hydrochloride, Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Multiple Myeloma
A Phase 1 study, sponsored by University of Washington.
- Terminated
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT00849251: Clinical Trial Phase 1 study, sponsored by University of Washington.
NCT00849251 is a Phase 1 study that was terminated before completion, run by University of Washington. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00849251, a Phase 1 study, was terminated before completion, sponsored by University of Washington.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving pegylated liposomal doxorubicin hydrochloride together with bortezomib, cyclophosphamide, and dexamethasone may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects of giving pegylated liposomal doxorubicin hydrochloride together with bortezomib, cyclophosphamide, and dexamethasone and to see how well it works in treating patients with multiple myeloma
Primary Outcome
If 3 patients of cohort 1 require dose reduction of one or more of the medications for toxicity attributed to the drug or drugs, then the starting dose level will be reduced for that drug or drugs for future patients. The initial dosing of drugs for cohort 2 will be permitted to be one dose level above the maximal tolerated doses of cohort 1. Note that this Outcome Measure shows MTD for cyclophosphamide, bortezomib and doxorubicin. MTD for dexamethasone is include in a separate table due to the
Interventions
- DRUG cyclophosphamide
- DRUG dexamethasone
- DRUG pegylated liposomal doxorubicin hydrochloride
- DRUG bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-11 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
Why NCT00849251 stopped before completion
NCT00849251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 4 interventions - of which cyclophosphamide is the first listed.
NCT00849251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00849251 about?
NCT00849251 is a clinical study titled "Pegylated Liposomal Doxorubicin Hydrochloride, Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Multiple Myeloma". RATIONALE: Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some...
What is the current status of trial NCT00849251?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2008-11. Estimated completion is 2015-06.
What interventions are being tested in trial NCT00849251?
The interventions under investigation include: cyclophosphamide (DRUG), dexamethasone (DRUG), pegylated liposomal doxorubicin hydrochloride (DRUG), bortezomib (DRUG).
Who is sponsoring clinical trial NCT00849251?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00849251's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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