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NCT02492750 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage Multiple Myeloma
A Phase 1 study of Plasma Cell Myeloma and Smoldering Plasma Cell Myeloma, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02492750: Completed Phase 1 study of Plasma Cell Myeloma and Smoldering Plasma Cell Myeloma, sponsored by Mayo Clinic.
NCT02492750 is a Phase 1 study of Plasma Cell Myeloma and Smoldering Plasma Cell Myeloma that has completed, run by Mayo Clinic. The registered enrollment target is 14 participants, below the 208-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02492750, a Phase 1 study of Plasma Cell Myeloma and Smoldering Plasma Cell Myeloma, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This partially randomized phase I/II trial studies the side effects and best dose of anakinra when given together with lenalidomide and dexamethasone in treating patients with early stage multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or suppress 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, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether lenalidomide and dexamethasone are more effective with or without anakinra in treating patients with multiple myeloma.
Primary Outcome
Number of participants experiencing a dose-limiting toxicity (DLT) is reported below. Dose-limiting toxicity is graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Conditions Studied
Interventions
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- DRUG Dexamethasone
- DRUG Lenalidomide
- BIOLOGICAL Anakinra
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-04 |
| Est. Completion | 2019-09-13 |
| Phase | Phase 1 |
What the finished NCT02492750 record still lists
NCT02492750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 208-participant average among 32 other Plasma Cell Myeloma trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Plasma Cell Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT02492750 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT02492750 about?
NCT02492750 is a clinical study titled "Lenalidomide and Dexamethasone With or Without Anakinra in Treating Patients With Early Stage Multiple Myeloma". This partially randomized phase I/II trial studies the side effects and best dose of anakinra when given together with lenalidomide and dexamethasone in treating patients with early stage multiple myeloma. Biological therapies, such as lenalidomide and anakinra, may stimulate or suppress the immune ...
What is the current status of trial NCT02492750?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-04. Estimated completion is 2019-09-13.
What conditions does trial NCT02492750 study?
This clinical trial studies the following conditions: Plasma Cell Myeloma, Smoldering Plasma Cell Myeloma, Indolent Plasma Cell Myeloma.
What interventions are being tested in trial NCT02492750?
The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Dexamethasone (DRUG), Lenalidomide (DRUG), Anakinra (BIOLOGICAL).
Who is sponsoring clinical trial NCT02492750?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02492750 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02492750's enrollment target sits among peer trials
14 32nd of 32 higher than 1 of 32 other Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Plasma Cell 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.
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