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NCT00103506 · ClinicalTrials.gov registry record · Phase 3
Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
A Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 646
- Enrollment target
- 20
- Study locations
NCT00103506: Completed Phase 3 study of Multiple Myeloma, sponsored by Janssen Research & Development.
NCT00103506 is a Phase 3 study of Multiple Myeloma that has completed, run by Janssen Research & Development. The registered enrollment target is 646 participants, above the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00103506, a Phase 3 study of Multiple Myeloma, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 646 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy.
Primary Outcome
Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of \>=25% from lowest level in Serum M-component or (the absolute increase must be \>=0.5 gram per deciliter \[g/dL\]); Urine M component or (the absolute increase must be \>=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light ch
Conditions Studied
Interventions
- DRUG Bortezomib (VELCADE)
- DRUG Doxorubicin hydrochloride (DOXIL/CAELYX)
Study Locations (20)
California
- - Berkeley
- - Loma Linda
- - Los Angeles
- - Sacramento
Florida
- - Jacksonville
- - Miami
- - Stuart
- - West Palm Beach
Connecticut
- - Norwalk
- - Stamford
Louisiana
- - Metairie
- - New Orleans
Alabama
- - Alabaster
Arizona
- - Surprise
Georgia
- - Altanta
Idaho
- - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 646 participants |
| Start Date | 2004-12 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
What the finished NCT00103506 record still lists
NCT00103506 is an interventional study that assigns participants to a tested intervention. The registered 646 participants enrollment target is mid-sized for trials with a published cap, above the 545-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Bortezomib (VELCADE) is the first listed.
NCT00103506 names 20 study sites across 12 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00103506 about?
NCT00103506 is a clinical study titled "Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma". The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy.
What is the current status of trial NCT00103506?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 646 participants. The study started on 2004-12. Estimated completion is 2014-06.
What conditions does trial NCT00103506 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT00103506?
The interventions under investigation include: Bortezomib (VELCADE) (DRUG), Doxorubicin hydrochloride (DOXIL/CAELYX) (DRUG).
Who is sponsoring clinical trial NCT00103506?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00103506 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
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Where NCT00103506's enrollment target sits among peer trials
646 36th of 438 higher than 403 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma 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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