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NCT00398515 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide and Temsirolimus in Treating Patients With Previously Treated Multiple Myeloma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
NCT00398515: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00398515 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00398515, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
This phase I trial is studying the side effects and best dose of temsirolimus when given together with lenalidomide in treating patients with previously treated multiple myeloma. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may also stop the growth of cancer cells by blocking some of the enzymes needed for their growth. Giving lenalidomide together with temsirolimus may kill more cancer cells.
Primary Outcome
The MTD is the dose level at which less than 2 out of 6 patients experience dose limiting toxicities (DLT). The National Cancer Institute Common Terminology Criteria for Adverse events (CTCAE) version 3.0 will used to characterize toxicities.
Interventions
- OTHER laboratory biomarker analysis
- DRUG lenalidomide
- OTHER pharmacological study
- DRUG temsirolimus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2007-03 |
| Phase | Phase 1 |
What the finished NCT00398515 record still lists
NCT00398515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00398515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00398515 about?
NCT00398515 is a clinical study titled "Lenalidomide and Temsirolimus in Treating Patients With Previously Treated Multiple Myeloma". This phase I trial is studying the side effects and best dose of temsirolimus when given together with lenalidomide in treating patients with previously treated multiple myeloma. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, su...
What is the current status of trial NCT00398515?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2007-03.
What interventions are being tested in trial NCT00398515?
The interventions under investigation include: laboratory biomarker analysis (OTHER), lenalidomide (DRUG), pharmacological study (OTHER), temsirolimus (DRUG).
Who is sponsoring clinical trial NCT00398515?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00398515's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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