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NCT00097981 · ClinicalTrials.gov registry record · Phase 3
A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma
A Phase 3 study of Multiple Myeloma, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
- 20
- Study locations
NCT00097981: Completed Phase 3 study of Multiple Myeloma, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
NCT00097981 is a Phase 3 study of Multiple Myeloma that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 225 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00097981, a Phase 3 study of Multiple Myeloma, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.
Primary Outcome
Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Thalidomide
- DRUG DOXIL
Study Locations (20)
Florida
- - Boca Raton
- - Jacksonville
- - Miami
- - Orange City
- - Ormond Beach
California
- - Fountain Valley
- - Greenbrae
- - La Verne
- - Los Angeles
Maryland
- - Baltimore
- - Bethesda
Minnesota
- - Minneapolis
- - Saint Louis Park
Colorado
- - Denver
Connecticut
- - New London
Georgia
- - Lawrenceville
Illinois
- - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2005-01 |
| Est. Completion | 2009-10 |
| Phase | Phase 3 |
What the finished NCT00097981 record still lists
NCT00097981 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Dexamethasone is the first listed.
NCT00097981 names 20 study sites across 11 states, led by Florida, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT00097981 about?
NCT00097981 is a clinical study titled "A Study of Thalidomide Plus Dexamethasone (Thal-Dex) Versus DOXIL plusThalidomide Plus Dexamethasone (DOXIL -Thal-Dex) in Patients With Newly Diagnosed Multiple Myeloma". The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of ...
What is the current status of trial NCT00097981?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2005-01. Estimated completion is 2009-10.
What conditions does trial NCT00097981 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT00097981?
The interventions under investigation include: Dexamethasone (DRUG), Thalidomide (DRUG), DOXIL (DRUG).
Who is sponsoring clinical trial NCT00097981?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00097981 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00097981's enrollment target sits among peer trials
225 100th of 438 higher than 339 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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