NCT00445484

Brief 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. Giving lenalidomide together with vaccine therapy may make a stronger immune response and kill more cancer cells. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

July 24, 2015

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

2.2 years

First QC Date

March 7, 2007

Results QC Date

June 26, 2015

Last Update Submit

August 5, 2015

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage II multiple myelomastage III multiple myelomarefractory multiple myeloma

Outcome Measures

Primary Outcomes (4)

  • 6B Antibody Response to Prevnar Vaccine in Peripheral Blood

    Serum IgG levels against the PVC serotype were measured by ELISA

    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

    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

    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

    basline and 8 weeks after second vaccination

Study Arms (2)

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).

Biological: pneumococcal polyvalent vaccineDrug: 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).

Biological: pneumococcal polyvalent vaccineDrug: lenalidomide

Interventions

pneumococcal polyvalent vaccineBIOLOGICAL

Given intramuscularly

Group 1Group 2
lenalidomideDRUG

Given orally

Group 1Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

  • 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.

    PMID: 22241792RESULT

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

Pneumococcal VaccinesLenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr. Ivan Borrello
Organization
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
iborrell@jhmi.edu
(410) 955-4967

Study Officials

  • Ivan Borrello, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2007

First Posted

March 9, 2007

Study Start

January 1, 2007

Primary Completion

April 1, 2009

Study Completion

September 1, 2010

Last Updated

August 24, 2015

Results First Posted

July 24, 2015

Record last verified: 2015-08

Locations

US(1)