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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


NCT number NCT02041325
Study type Interventional
Source Boston VA Research Institute, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date April 2005

See also
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Active, not recruiting NCT03480360 - Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression Phase 3
Recruiting NCT04879043 - Study to Assess Safety of HDP-101 in Patients With Relapsed Refractory Multiple Myeloma Phase 1/Phase 2
Completed NCT02274519 - Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma N/A
Not yet recruiting NCT06313502 - High Dose Ascorbic Acid (HDAA) in Patients With Plasma Cell Disorders Phase 1
Not yet recruiting NCT06330896 - Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing