Investigation of the Enhancement of Response to Hepatitis B Vaccine by Lenalidomide in Plasma Cell Dyscrasias

NCT02041325 | Completed Phase 2 Results DMC

• 1 other identifier: IRB 1831
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Plasma Cell Disorder

Outcome Measures

Primary Outcomes (1)

• Positive for Hepatitis B Surface Antigen

  The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).

  6 weeks

Secondary Outcomes (3)

• Safety

  6 weeks

• Quantity of Subjects With a T-cell Response

  6 weeks

• Phenotypic Changes

  6 weeks

Study Arms (2)

Lenalidomide

EXPERIMENTAL

Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.

Drug: Lenalidomide

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.

Drug: Placebo

Interventions

Lenalidomide DRUG

Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.

Also known as: CC-5013, Revlimid

Lenalidomide

Placebo DRUG

Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston VA Research Institute, Inc.: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (2)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

Lenalidomide; Sugars

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Results Point of Contact

• Title: Dr. Nikhil C. Munshi
• Organization: BVARI

nikhil_munshi@va.gov

857-203-6172

Study Officials

• Nikhil C Munshi, M.D.

  VA Boston Healthcare System; Harvard Medical School; Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine Harvard Medical School; Physician

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 22, 2014
• Study Start: April 1, 2005
• Primary Completion: January 1, 2011
• Study Completion: April 1, 2014
• Last Updated: May 17, 2016
• Results First Posted: May 17, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)