Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02041325 · ClinicalTrials.gov registry record · Phase 2
Investigation of the Enhancement of Response to Hepatitis B Vaccine by Lenalidomide in Plasma Cell Dyscrasias
A Phase 2 study, sponsored by Boston VA Research Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT02041325 is a Phase 2 study that has completed, run by Boston VA Research Institute. The registered enrollment target is 38 participants.
The verdict
NCT02041325, a Phase 2 study, has completed, sponsored by Boston VA Research Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
This is a research study to determine if the study drug lenalidomide will increase the body's immune response, which is the body's response against infections or tumors, to hepatitis B vaccine in patients with plasma cell diseases which include multiple myeloma, monoclonal gammopathy of unknown significance (MGUS) and Waldenström's Macroglobulinemia. It is not a study to see if lenalidomide is an effective treatment for plasma cell disease. Participants in this study have multiple myeloma or other plasma cell disease and have never been vaccinated with hepatitis B vaccine. One of the effects of the drug lenalidomide is to alter the immune system and thereby increase immune response. It also has some effect against cancer cells; therefore, in theory, it may reduce or prevent the growth of cancer cells. In this study, one-half of the subjects will be chosen at random to receive the study drug and the other half will take a placebo pill (a sugar pill that looks the same as the real medication). This is a double blind study where neither the subjects nor the investigators know whether the patient receives the study drugs or placebo pills. The effects of the active drug lenalidomide will be compared to the effects of the placebo. The results from this study will be also be compared with a similar but separate study to be done on individuals without known disease. This study expects to enroll 64 subjects and will be carried out at the Boston VA Healthcare System and the Dana Farber Cancer Institute.
Interventions
- DRUG Placebo
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2005-04 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02041325
The ClinicalTrials.gov registry entry for NCT02041325 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 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 Placebo is the first listed.
NCT02041325 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02041325 about?
NCT02041325 is a clinical study titled "Investigation of the Enhancement of Response to Hepatitis B Vaccine by Lenalidomide in Plasma Cell Dyscrasias". This is a research study to determine if the study drug lenalidomide will increase the body's immune response, which is the body's response against infections or tumors, to hepatitis B vaccine in patients with plasma cell diseases which include multiple myeloma, monoclonal gammopathy of unknown sign...
What is the current status of trial NCT02041325?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2005-04. Estimated completion is 2014-04.
What interventions are being tested in trial NCT02041325?
The interventions under investigation include: Placebo (DRUG), Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT02041325?
This trial is sponsored by Boston VA Research Institute, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.