Investigation of the Enhancement of the Response to Hepatitis B Vaccine by Lenalidomide (RevlimidTM, CC-5013) in Plasma Cell Dyscrasias

Plasma Cell Disorder Clinical Trial

Official title:

Investigation of the Enhancement of the Response to Hepatitis B Vaccine by Lenalidomide (RevlimidTM, CC-5013) in Plasma Cell Dyscrasias

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02041325
• Other study ID #: IRB 1831
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 14, 2014
• Last updated: January 17, 2014
• Start date: April 2005

Study information

• Verified date: January 2014
• Source: Boston VA Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: VA Boston Healthcare System Human Studies Subcommittee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Understand and voluntarily sign an informed consent form.

• Age > = 18 years at the time of signing the informed consent form.

• Able to adhere to the study visit schedule and other protocol requirements.

• Must have confirmed diagnosis of plasma cell disorder.

• Patients with prior thalidomide or CC-5013 (lenalidomide) use are eligible but these agents must have been discontinued at least 4 weeks prior to treatment in this study.

• All previous cancer therapy, including chemotherapy, and dexamethsone must have been discontinued at least 4 weeks prior to treatment in this study. Patients with recent radiation, hormonal therapy and surgery are eligible.

• Patients must not have received prior Hepatitis B vaccination.

• Patient should be negative for antibody against HbSAg.

• ANC >= 1000, Platelets >= 75,000.

• Women of childbearing potential (WCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active WCBP must agree to use two of the following adequate forms of contraception throughout the entire study (tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner). A WCBP must agree to have pregnancy tests 4 weeks after her last dose of lenalidomide. Due to the short duration of drug therapy, abstinence would also be a reasonable option.

Exclusion Criteria:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

• Pregnant or lactating females.

• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

• Use of any other experimental drug or therapy within 28 days of baseline.

• Known hypersensitivity to thalidomide.

• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.

• Concurrent use of other anti-cancer agents or treatments.

• Known HIV, HBV and HCV positivity.

• Clinically significant autoimmune disease.

• Serious intercurrent illness such as active infection requiring IV antibiotics, significant cardiac or pulmonary disease.

• Psychiatric disorder, alcohol or illicit drug use.

Study Design

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

Related Conditions & MeSH terms

• Hepatitis B
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Disorder

Intervention

Drug:
• Lenalidomide

• Placebo

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	VA Boston Healthcare System	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston VA Research Institute, Inc.	Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatitis B surface antigen	Antibody titer against hepatitis B surface antigen (HbSAg).	6 weeks	No
Secondary	Safety	Number of participants with adverse events as a measure of safety and tolerability	6 weeks	Yes
Secondary	T-cell response	T cell responses against HbSAg following vaccination	6 weeks	No
Secondary	Phenotypic changes	Phenotypic changes in peripheral blood cells following CC-5013 (lenalidomide) administration especially in regards to CD3, CD4, CD8 T cells, and NK and NKT cells.	6 weeks	No
Secondary	Gene Expression Profile of Immune cells	Changes in gene expression profile of immune cells before and after the treatment of CC-5013 (lenalidomide) using micro array protocols.	6 weeks	No