Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00445484

Lenalidomide and Vaccine Therapy in Treating Patients With Relapsed or Refractory Multiple Myeloma

A Phase 2 study testing pneumococcal polyvalent vaccine and lenalidomide in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site 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

RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines may help the body build an effective immune response to kill cancer cells. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma and Plasma Cell Neoplasm
What is being tested?: pneumococcal polyvalent vaccine and lenalidomide
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Jan 2007to Sep 2010
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

DISEASE CHARACTERISTICS:

Diagnosis of multiple myeloma (MM) meeting all of the following criteria:
Relapsed or refractory disease
Previously received ≥ 2 courses of antimyeloma treatment
Measurable levels of myeloma paraprotein in serum (> 0.5 g/dL) or urine (> 0.2 g/24-hour urine collection) OR serum-free light-chain disease

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Absolute neutrophil count ≥ 1,000/mm^3
Platelet count ≥ 75,000/mm^3
Creatinine ≤ 2.5 mg/dL
Bilirubin ≤ 2.0 mg/dL
AST and ALT ≤ 3 times upper limit of normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 methods of highly effective contraception ≥ 4 weeks before, during, and for 4 weeks after completion of study therapy
No other malignancy within the past 5 years except treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
No serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study treatment or put patient at unacceptable risk
No known hypersensitivity to thalidomide or lenalidomide
No development of erythema nodosum in the presence of a reaction characterized by a desquamating rash while taking thalidomide or similar drugs
No known hypersensitivity to any component of the pneumococcal polyvalent vaccine, including diphtheria toxin or CRM 197
No known HIV positivity
No infectious hepatitis type A, B, or C

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No more than 3 prior treatment regimens for MM
More than 6 months since prior lenalidomide
More than 28 days since prior experimental drug or therapy
More than 1 month since prior systemic antimyeloma therapy
More than 1 month since prior and no concurrent systemic corticosteroids
No other concurrent anticancer agents or treatments or investigational agents
No concurrent thalidomide
No concurrent radiotherapy
No other concurrent immune therapy or immunomodulatory agents

Trial locations and contacts

1 site in 1 country.

United States1 site

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410

Other trials in United States

About this study

Official title: Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma

PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed or refractory multiple myeloma.

Read the detailed description

OBJECTIVES:

Primary

Determine whether lenalidomide can augment the efficacy of pneumococcal polyvalent vaccine as it correlates with lenalidomide-induced antitumor efficacy in patients with relapsed or refractory multiple myeloma.

Secondary

Determine the antibody responses to pneumococcal serotypes in patients treated with this regimen.
Determine T-cell responses to the carrier protein CRM 197 in patients treated with this regimen.
Determine the ability of lenalidomide to augment in vivo immune responsiveness as measured by cutaneous delayed-type hypersensitivity (DTH) reactions to Candida and tetanus in these patients.
Determine the ability of lenalidomide to prime and/or boost systemic vaccine responses in both peripheral blood lymphocytes and marrow lymphocytes in these patients.

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

Group 1: Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
Group 2: Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Being tested: pneumococcal polyvalent vaccine, lenalidomide
Keywords: stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
Medical subject headings: Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

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

pneumococcal polyvalent vaccineBiological
Given intramuscularly
lenalidomideDrug
Given orally

Study groups in NCT00445484
Study group	Role	What they receive
Group 1	Experimental	Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine). Receives: Biological: pneumococcal polyvalent vaccine; Drug: lenalidomide
Group 2	Experimental	Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine). Receives: Biological: pneumococcal polyvalent vaccine; Drug: lenalidomide

What is being measured

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

6B Antibody Response to Prevnar Vaccine in Peripheral Blood
Serum IgG levels against the PVC serotype were measured by ELISA
Measured: basline and 8 weeks after second vaccination
14F Antibody Response to Prevnar Vaccine in Peripheral Blood
Serum IgG levels against the PVC serotype were measured by ELISA
Measured: basline and 8 weeks after second vaccination
19F Antibody Response to Prevnar Vaccine in Peripheral Blood
Serum IgG levels against the PVC serotype were measured by ELISA
Measured: basline and 8 weeks after second vaccination
23F Antibody Response to Prevnar Vaccine in Peripheral Blood
Serum IgG levels against the PVC serotype were measured by ELISA
Measured: basline and 8 weeks after second vaccination

Timeline

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

Jan 2007Sep 2010

First posted9 Mar 2007 (estimated)
Study startJan 2007
Primary completionApr 2009
Study completionSep 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple Myeloma and Plasma Cell NeoplasmStudies of the same condition, open and under way.
More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00445484
Sponsor's protocol ID: J06102 CDR0000532944
Other IDs: P30CA006973, JHOC-J06102, JHOC-NA_00006008, CELGENE-CC-5013
Status last verified: Aug 2015
First submitted: 7 Mar 2007
Last updated: 24 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Noonan K, Rudraraju L, Ferguson A, Emerling A, Pasetti MF, Huff CA, Borrello I. Lenalidomide-induced immunomodulation in multiple myeloma: impact on vaccines and antitumor responses. Clin Cancer Res. 2012 Mar 1;18(5):1426-34. doi: 10.1158/1078-0432.CCR-11-1221. Epub 2012 Jan 12.
PubMed 22241792

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
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma and Plasma Cell Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Revlimid to Augment Efficacy of Prevnar Vaccines in Patients With Relapsed or Refractory Myeloma
ClinicalTrials.gov ID: NCT00445484
Acronym / sponsor ID: J06102 CDR0000532944
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jan 2007
Primary completion: Apr 2009 (actual)
Study completion: Sep 2010 (actual)
First posted: 9 Mar 2007 (estimated)
Results: Posted 24 Jul 2015

Clinical summary

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

PURPOSE: This phase II trial is studying how well giving lenalidomide together with vaccine therapy works in treating patients with relapsed or refractory multiple myeloma.

Detailed description

OBJECTIVES:

Primary

Determine whether lenalidomide can augment the efficacy of pneumococcal polyvalent vaccine as it correlates with lenalidomide-induced antitumor efficacy in patients with relapsed or refractory multiple myeloma.

Secondary

Determine the antibody responses to pneumococcal serotypes in patients treated with this regimen.
Determine T-cell responses to the carrier protein CRM 197 in patients treated with this regimen.
Determine the ability of lenalidomide to augment in vivo immune responsiveness as measured by cutaneous delayed-type hypersensitivity (DTH) reactions to Candida and tetanus in these patients.
Determine the ability of lenalidomide to prime and/or boost systemic vaccine responses in both peripheral blood lymphocytes and marrow lymphocytes in these patients.

OUTLINE: Patients are assigned to 1 of 2 treatment groups.

Group 1: Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
Group 2: Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).

After completion of study treatment, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Experimental	Biological: pneumococcal polyvalent vaccine, Drug: lenalidomidePatients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).
Group 2	Experimental	Biological: pneumococcal polyvalent vaccine, Drug: lenalidomidePatients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).

Who may qualify

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

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
pneumococcal polyvalent vaccineGiven intramuscularly	Biological	Group 1, Group 2
lenalidomideGiven orally	Drug	Group 1, Group 2

Primary outcome

6B Antibody Response to Prevnar Vaccine in Peripheral Blood
Time frame: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA
14F Antibody Response to Prevnar Vaccine in Peripheral Blood
Time frame: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA
19F Antibody Response to Prevnar Vaccine in Peripheral Blood
Time frame: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA
23F Antibody Response to Prevnar Vaccine in Peripheral Blood
Time frame: basline and 8 weeks after second vaccination
Serum IgG levels against the PVC serotype were measured by ELISA

Results and safety

Results posted to the registry on 24 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 2	11	7
Group 1	11	10

Primary outcome: 6B Antibody Response to Prevnar Vaccine in Peripheral Blood

Time frame: basline and 8 weeks after second vaccination. Mean (Standard Error). Unit: fold change

Measure	Vaccine Started 14 Days Prior to Lenalidomide n = 8	Vaccine Started 45 Days After Lenalidomide n = 5
Value	3.69 (1.1)	7.58 (3.0)

Population analysed: Patients who showed evidence of disease progression while on study were not included in the analysis.

Primary outcome: 14F Antibody Response to Prevnar Vaccine in Peripheral Blood

Time frame: basline and 8 weeks after second vaccination. Mean (Standard Error). Unit: fold change

Measure	Vaccine Started 14 Days Prior to Lenalidomide n = 5	Vaccine Started 45 Days After Lenalidomide n = 8
Value	9.42 (5.0)	11.95 (3.8)

Population analysed: Patients who showed evidence of disease progression while on study were not included in the analysis.

Primary outcome: 19F Antibody Response to Prevnar Vaccine in Peripheral Blood

Time frame: basline and 8 weeks after second vaccination. Mean (Standard Error). Unit: fold change

Measure	Vaccine Started 14 Days Prior to Lenalidomide n = 8	Vaccine Started 45 Days After Lenalidomide n = 5
Value	2.025 (0.64)	2.12 (0.4)

Population analysed: Patients who showed evidence of disease progression while on study were not included in the analysis.

Primary outcome: 23F Antibody Response to Prevnar Vaccine in Peripheral Blood

Time frame: basline and 8 weeks after second vaccination. Mean (Standard Error). Unit: fold change

Measure	Vaccine Started 14 Days Prior to Lenalidomide n = 8	Vaccine Started 45 Days After Lenalidomide n = 5
Value	4.1 (1.8)	2.42 (1)

Population analysed: Patients who showed evidence of disease progression while on study were not included in the analysis.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	1 of 11 (9.1%)	1 of 11 (9.1%)	Not reported
Group 2	0 of 11 (0%)	1 of 11 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22241792Noonan K, Rudraraju L, Ferguson A, Emerling A, Pasetti MF, Huff CA, Borrello I. Lenalidomide-induced immunomodulation in multiple myeloma: impact on vaccines and antitumor responses. Clin Cancer Res. 2012 Mar 1;18(5):1426-34. doi: 10.1158/1078-0432.CCR-11-1221. Epub 2012 Jan 12.

Related trials for Multiple Myeloma and Plasma Cell Neoplasm

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
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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.

Ivan Borrello, MD study chair

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Questions about this trial

What is this clinical trial studying?

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

Who may be eligible to take part?

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 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 24 Jul 2015). 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?

6B Antibody Response to Prevnar Vaccine in Peripheral Blood (time frame: basline and 8 weeks after second vaccination). The study lists 4 primary outcomes in all. 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 NCT00445484, which also lists 1 linked publication.

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 24 Aug 2015.