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NCT01380106 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma
A Phase 2 study, sponsored by Boston VA Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT01380106 is a Phase 2 study that has completed, run by Boston VA Research Institute. The registered enrollment target is 33 participants.
The verdict
NCT01380106, a Phase 2 study, has completed, sponsored by Boston VA Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in combination with low dose dexamethasone in patients with relapsed multiple myeloma. The investigators propose to use the need for dose reduction as a criterion to judge tolerability from various causes. In the veteran population which predominantly is in the older age category with number of co-morbidities, a lower dose regimen may be safer and advantageous. This study expects to enroll approximately 80 subjects from participating VA sites across the nation. The investigators will evaluate the safety of the two dose regimens by comparing frequency of dose reductions. The investigators will also measure how long the responses last with each dose. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental. At the time of enrollment, one-half of the subjects will be chosen at random to receive the 15 mg Lenalidomide dose and the other half will take the 25 mg dose regimen of Lenalidomide. Depending on lenalidomide treatment assignment, subjects will receive either 15 mg p.o. q.d. or 25 mg p.o. q.d. for days 1-21 of a 28 day cycle. In addition, dexamethasone (40 mg) will be added once a week (Days 1, 8, 15 and 22) to the Lenalidomide regimen, with a dose reduction on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. ASA (81 or 325mg) will be given daily for anticoagulation prophylaxis. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.
Interventions
- DRUG Lenalidomide 15mg
- DRUG Lenalidomide 25mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2010-08 |
| Est. Completion | 2017-09-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01380106
The ClinicalTrials.gov registry entry for NCT01380106 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston VA Research Institute, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lenalidomide 15mg is the first listed.
NCT01380106 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01380106 about?
NCT01380106 is a clinical study titled "Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma". This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in combination with low dose dexamethasone in patients with relapsed multiple myeloma. The investigators propose to use the need for dose reduction as a criterion to judge tolerability from various causes. In th...
What is the current status of trial NCT01380106?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2010-08. Estimated completion is 2017-09-11.
What interventions are being tested in trial NCT01380106?
The interventions under investigation include: Lenalidomide 15mg (DRUG), Lenalidomide 25mg (DRUG).
Who is sponsoring clinical trial NCT01380106?
This trial is sponsored by Boston VA Research Institute, which has 12 total clinical trials registered on ClinicalTrials.gov.
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