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NCT01675141 · ClinicalTrials.gov registry record · Phase 2
Lenalidomide Maintenance Therapy for Multiple Myeloma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01675141: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01675141 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01675141, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
Background: * Multiple myeloma is rarely curable, but it is treatable. Initial treatment is directed at controlling symptoms and reducing the number of myeloma cells. It continues until the cancer stops responding to treatment. At that time, treatment may switch to maintenance therapy, which is given to try to extend the response of the first therapy for as long as possible. Research suggests that lenalidomide maintenance therapy may delay the time for myeloma cells to start to grow and possibly improve survival. * Lenalidomide is a drug that may reduce or prevent the growth of cancer cells. Researchers want to look at the long-term effect of lenalidomide on immune cells. It will also look at the effects of extended treatment on the cancer and the immune system. Objectives: \- To test the long-term effectiveness of lenalidomide therapy for multiple myeloma. Eligibility: \- Individuals at least 18 years of age with newly diagnosed or relapsed multiple myeloma. Design: * Participants will be screened with a physical exam and medical history. Blood and urine sample will be collected. A bone scan and bone marrow biopsy will also be performed. * Participants will receive lenalidomide maintenance treatment. It will be given according to the standard of care for multiple myeloma. Participants will take lenalidomide every day for 21 days of repeated 28-day cycles. * Treatment will be monitored with frequent blood tests. Blood tests will look at the effect of the treatment on the immune system. * Treatment will continue as long as the cancer does not worsen and the side effects are not severe.
Primary Outcome
Peripheral blood samples will be collected to assess T cell (CD4, CD8), NKT and NK cell counts using flow cytometry.
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-08-20 |
| Est. Completion | 2017-03-10 |
| Phase | Phase 2 |
Why NCT01675141 stopped before completion
NCT01675141 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT01675141 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01675141 about?
NCT01675141 is a clinical study titled "Lenalidomide Maintenance Therapy for Multiple Myeloma". Background: * Multiple myeloma is rarely curable, but it is treatable. Initial treatment is directed at controlling symptoms and reducing the number of myeloma cells. It continues until the cancer stops responding to treatment. At that time, treatment may switch to maintenance therapy, which is giv...
What is the current status of trial NCT01675141?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2012-08-20. Estimated completion is 2017-03-10.
What interventions are being tested in trial NCT01675141?
The interventions under investigation include: Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT01675141?
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 NCT01675141's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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