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NCT00790842 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction
A Phase 1 study, sponsored by PrECOG.
- Terminated
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT00790842: Clinical Trial Phase 1 study, sponsored by PrECOG.
NCT00790842 is a Phase 1 study that was terminated before completion, run by PrECOG. The registered enrollment target is 63 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00790842, a Phase 1 study, was terminated before completion, sponsored by PrECOG.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study Summary
Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose is found in Phase I, the study will proceed to Phase II. Phase II will study how well the the treatment works in patients with previously treated (relapsed or refractory) multiple myeloma and kidney dysfunction. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with dexamethasone may kill more cancer cells. Lenalidomide and dexamethasone may have different effects in patients who have changes in their kidney function.
Primary Outcome
Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved: * Grade 3 or higher neutropenia with fever ≥38.5 degrees C * Grade 4 neutropenia ≥7 days * Grade 4 or higher thrombocytopenia * Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Anticoagulants
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2009-01-21 |
| Est. Completion | 2018-03-08 |
| Phase | Phase 1 |
Why NCT00790842 stopped before completion
NCT00790842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT00790842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00790842 about?
NCT00790842 is a clinical study titled "Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction". Patients with previously treated multiple myeloma and kidney dysfunction will be treated with lenalidomide and low-dose dexamethasone. Phase I will study the side effects and best dose of lenalidomide when given together with low-dose dexamethasone therapy. After the maximum safe and tolerated dose ...
What is the current status of trial NCT00790842?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2009-01-21. Estimated completion is 2018-03-08.
What interventions are being tested in trial NCT00790842?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Anticoagulants (DRUG).
Who is sponsoring clinical trial NCT00790842?
This trial is sponsored by PrECOG, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00790842's enrollment target sits among peer trials
63 820th of 2000 higher than 1,177 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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