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NCT00378209 · ClinicalTrials.gov registry record · Phase 2
Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma
A Phase 2 study of Multiple Myeloma, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 2
- Study locations
NCT00378209: Completed Phase 2 study of Multiple Myeloma, sponsored by Dana-Farber Cancer Institute.
NCT00378209 is a Phase 2 study of Multiple Myeloma that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 65 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00378209, a Phase 2 study of Multiple Myeloma, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate the effectiveness and side effects of the bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory multiple myeloma. Each of these drugs are approved by the U.S Food and Drug Administration, but have not been approved in the combination for treating patients in this setting.
Primary Outcome
Response assessed by the European Group for Blood and Marrow Transplant (EBMT) criteria, modified to include nCR and VGPR from the international uniform response criteria (IMWG). Progressive disease (PD) required one or more of the following: \>25% increased in serum monoclonal paraprotein (must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation) \>25% increased in 24-hour urinary light chain excretion (must also be an absolute increase of at least 200 mg/24
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Bortezomib
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2006-08 |
| Est. Completion | 2016-10 |
| Phase | Phase 2 |
What the finished NCT00378209 record still lists
NCT00378209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (88% 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.
NCT00378209 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00378209 about?
NCT00378209 is a clinical study titled "Bortezomib, Lenalidomide, and Dexamethasone Combination Therapy for Patients With Relapsed or Relapsed and Refractory Multiple Myeloma". The purpose of this study is to evaluate the effectiveness and side effects of the bortezomib, lenalidomide and dexamethasone combination in relapsed or relapsed and refractory multiple myeloma. Each of these drugs are approved by the U.S Food and Drug Administration, but have not been approved in t...
What is the current status of trial NCT00378209?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2006-08. Estimated completion is 2016-10.
What conditions does trial NCT00378209 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT00378209?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT00378209?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00378209 being conducted?
This trial has 2 study locations across Massachusetts. 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 NCT00378209's enrollment target sits among peer trials
65 220th of 438 higher than 217 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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