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NCT00617591 · ClinicalTrials.gov registry record · Phase 2
Pegylated Liposomal Doxorubicin, Low Freq Dexamethasone & Revlimid (Dd-R) in Newly Diagnosed Multiple Myeloma (MM)
A Phase 2 study of Multiple Myeloma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT00617591: Completed Phase 2 study of Multiple Myeloma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT00617591 is a Phase 2 study of Multiple Myeloma that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 57 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00617591, a Phase 2 study of Multiple Myeloma, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the research study is to determine the response rates when Revlimid® is combined with Doxil® and Dexamethasone (Dd-R) in newly diagnosed Multiple Myeloma. The study will also evaluate the side effects caused by the combination of these three drugs. This therapy is investigational in the treatment of Multiple Myeloma. Revlimid® is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Revlimid® is approved by the Food and Drug Administration (FDA) for specific types of myelodysplastic syndrome (MDS) and Multiple Myeloma, two different types of blood cancer. It is currently being tested in a variety of other cancer conditions. In this case it is considered experimental. Doxil® is a form of chemotherapy. It is approved by the FDA for the treatment of relapsed/ refractory Multiple Myeloma in combination with Velcade. Dexamethasone is a steroid. It is also approved by the FDA, but not for the treatment of Multiple Myeloma. It is considered a standard part of most myeloma therapies for newly diagnosed patients.
Primary Outcome
ORR assessed using International Myeloma Working Group Response Definitions. Partial Remission (PR): A greater than 50% reduction in the serum paraprotein, and if present, a greater than 90% reduction in the urine M protein excretion. Patients must also have a decrease by 50% in the size of soft tissue plasmacytoma. If serum and urine M protein are not measurable, a 50% or greater decreased in the difference of the involved and uninvolved free light chain. Very Good Partial Remission (VGPR): Det
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Pegylated Liposomal Doxorubicin (PLD)
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2008-01 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT00617591 record still lists
NCT00617591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (90% 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.
NCT00617591 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT00617591 about?
NCT00617591 is a clinical study titled "Pegylated Liposomal Doxorubicin, Low Freq Dexamethasone & Revlimid (Dd-R) in Newly Diagnosed Multiple Myeloma (MM)". The purpose of the research study is to determine the response rates when Revlimid® is combined with Doxil® and Dexamethasone (Dd-R) in newly diagnosed Multiple Myeloma. The study will also evaluate the side effects caused by the combination of these three drugs. This therapy is investigational in t...
What is the current status of trial NCT00617591?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2008-01. Estimated completion is 2013-04.
What conditions does trial NCT00617591 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT00617591?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Pegylated Liposomal Doxorubicin (PLD) (DRUG).
Who is sponsoring clinical trial NCT00617591?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00617591 being conducted?
This trial has 1 study location across Florida. 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 NCT00617591's enrollment target sits among peer trials
57 235th of 438 higher than 201 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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