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NCT00839956 · ClinicalTrials.gov registry record · Phase 2
Bortezomib and Vorinostat in Treating Patients With Multiple Myeloma Who Have Undergone Autologous Stem Cell Transplant
A Phase 2 study of DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT00839956: Completed Phase 2 study of DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma, sponsored by Fred Hutchinson Cancer Center.
NCT00839956 is a Phase 2 study of DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 31 participants, below the 59-participant average among 5 other DS Stage I Plasma Cell Myeloma trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00839956, a Phase 2 study of DS Stage I Plasma Cell Myeloma and DS Stage II Plasma Cell Myeloma, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the side effects of giving bortezomib together with vorinostat and to see how well it works in treating patients with multiple myeloma who have undergone autologous stem cell transplant. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat after an autologous stem cell transplant may stop the growth of any cancer cells that remain after transplant.
Primary Outcome
The first three months of therapy will be used as the time period in which toxicity will be evaluated and stopping rules for unacceptable toxicity will be implemented. Rules for stopping the study will be based on the rate of withdrawal due to significant toxicity (grade IV, non-hematological, non-metabolic, nonperipheral neuropathy).
Conditions Studied
Interventions
- DRUG Bortezomib
- DRUG Vorinostat
Study Locations (1)
Washington
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2009-02 |
| Est. Completion | 2017-03-31 |
| Phase | Phase 2 |
What the finished NCT00839956 record still lists
NCT00839956 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 59-participant average among 5 other DS Stage I Plasma Cell Myeloma trials with a reported enrollment target (47% lower).
The record links to 3 conditions, with DS Stage I Plasma Cell Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Bortezomib is the first listed.
NCT00839956 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT00839956 about?
NCT00839956 is a clinical study titled "Bortezomib and Vorinostat in Treating Patients With Multiple Myeloma Who Have Undergone Autologous Stem Cell Transplant". This phase II trial studies the side effects of giving bortezomib together with vorinostat and to see how well it works in treating patients with multiple myeloma who have undergone autologous stem cell transplant. Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the...
What is the current status of trial NCT00839956?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2009-02. Estimated completion is 2017-03-31.
What conditions does trial NCT00839956 study?
This clinical trial studies the following conditions: DS Stage I Plasma Cell Myeloma, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma.
What interventions are being tested in trial NCT00839956?
The interventions under investigation include: Bortezomib (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT00839956?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00839956 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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