Plasma Cell DisorderPhase 2NCT02041325

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

A Phase 2 study testing Lenalidomide in people with Plasma Cell Disorder, run by Boston VA Research Institute, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Plasma Cell Disorder
What is being tested?: Lenalidomide
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 2 sitesUnited States
Study dates: Apr 2005to Apr 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

VA Boston Healthcare System
Boston, Massachusetts, 02130
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215

Other trials in United States

About this study

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

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.

Read the detailed description

The primary object of this study is to evaluate the effect of CC-5013 on the response to hepatitis B vaccine in myeloma. Secondary objectives include the evaluation of immunologic and functional genomic changes following CC-55013.

This study will be a two-center, randomized, double-blinded, placebo-controlled trial. A single dose of Hepatitis B vaccine will be administered to subjects. CC-5013 or placebo will be administered for 7 days prior to and 7 days after the vaccine. Collection of samples for immune analysis will be performed prior to the initiation of CC-5013 administration, at the time of vaccination, and 7, 14, and 28 days after vaccination. Safety assessment will be performed at each visit.

Primary Endpoint

Titer of antibodies to hepatitis B virus Secondary Endpoints
Immune analysis
Hepatitis B related T cell response
Safety profile

All the patients should not have a prior response against hepatitis B surface antigen. The study will be comprised of 64 multiple myeloma patients who have not taken any therapeutic agents in the 30 days prior to enrollment in the study. Subjects will be randomly assigned to receive or not receive CC-5013, and all will be vaccinated. The study is designed to detect a biological difference of 50% with an alpha of 0.05 and a beta of 0.8.

Conditions: Plasma Cell Disorder
Being tested: Lenalidomide, Placebo
Medical subject headings: Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LenalidomideDrug
Also called CC-5013, Revlimid
Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
PlaceboDrug
Also called Sugar pill
Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.

Study groups in NCT02041325
Study group	Role	What they receive
Lenalidomide	Experimental	Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine. Receives: Drug: Lenalidomide
Placebo	Placebo comparator	Subjects will receive placebo for 7 days prior to and 7 days after the vaccine. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Positive for Hepatitis B Surface Antigen
The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).
Measured: 6 weeks

Secondary outcomes (3)

Safety
Number of participants with adverse events as a measure of safety and tolerability
Measured: 6 weeks
Quantity of Subjects With a T-cell Response
Participants who displayed a T cell responses against HbSAg following vaccination
Measured: 6 weeks
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.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2005Apr 2014

First posted22 Jan 2014 (estimated)
Study startApr 2005
Primary completionJan 2011
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Plasma Cell DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02041325
Sponsor's protocol ID: IRB 1831
Status last verified: Apr 2016
First submitted: 14 Jan 2014
Last updated: 17 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease

All Plasma Cell Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Enhancement of the Response to Hepatitis B Vaccine by Lenalidomide (RevlimidTM, CC-5013) in Plasma Cell Dyscrasias
ClinicalTrials.gov ID: NCT02041325
Acronym / sponsor ID: IRB 1831
Conditions: Plasma Cell Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Boston VA Research Institute, Inc.University, hospital or other
Collaborators: Dana-Farber Cancer Institute
Study start: Apr 2005
Primary completion: Jan 2011 (actual)
Study completion: Apr 2014 (actual)
First posted: 22 Jan 2014 (estimated)
Results: Posted 17 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study expects to enroll 64 subjects and will be carried out at the Boston VA Healthcare System and the Dana Farber Cancer Institute.

Detailed description

Primary Endpoint

Titer of antibodies to hepatitis B virus Secondary Endpoints
Immune analysis
Hepatitis B related T cell response
Safety profile

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Lenalidomide	Experimental	Drug: LenalidomideSubjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
Placebo	Placebo comparator	Drug: PlaceboSubjects will receive placebo for 7 days prior to and 7 days after the vaccine.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LenalidomideAlso: CC-5013, RevlimidSubjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.	Drug	Lenalidomide
PlaceboAlso: Sugar pillSubjects will receive placebo for 7 days prior to and 7 days after the vaccine.	Drug	Placebo

Primary outcome

Positive for Hepatitis B Surface Antigen
Time frame: 6 weeks
The number of participants who test positive for the antibody titer against hepatitis B surface antigen (HbSAg).

3 secondary outcomes

Safety
Time frame: 6 weeks
Quantity of Subjects With a T-cell Response
Time frame: 6 weeks
Phenotypic Changes
Time frame: 6 weeks

Results and safety

Results posted to the registry on 17 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lenalidomide	22	19
Placebo	16	13

Primary outcome: Positive for Hepatitis B Surface Antigen

Time frame: 6 weeks. Number. Unit: participants

Measure	Lenalidomide n = 22	Placebo n = 16
Value	4	3

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lenalidomide	2 of 22 (9.1%)	0 of 22 (0%)	Not reported
Placebo	2 of 16 (12.5%)	0 of 16 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Plasma Cell Disorder

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingObservational study
Patient-Specific MRD Liquid Biopsy in Resected NSCLC: Plasma and Bronchial Washing ctDNA
Non-Small Cell Lung Cancer, Minimal Residual Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nikhil C Munshi, M.D. principal investigator

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide in people with Plasma Cell Disorder, run by Boston VA Research Institute, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive for Hepatitis B Surface Antigen (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02041325.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2016.