Trial Summary
What is the purpose of this trial?This study is evaluating whether a vaccine which targets a protein found in cancer cells may help treat multiple myeloma.
Eligibility Criteria
This trial is for newly diagnosed multiple myeloma patients who've responded to initial therapy, have specific HLA types (HLA-A*02, A*03, A*11, or A*24), and meet certain health criteria like good organ function and no serious infections. They must not be pregnant or breastfeeding and should agree to the Revlimid REMS® program's requirements.Inclusion Criteria
I have one of the required HLA types for the study.
My multiple myeloma has partially improved after initial treatment.
I can take care of myself but might not be able to do heavy physical work.
My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).
Exclusion Criteria
I have had an autoimmune disease that needed strong medication.
I developed a peeling rash from taking thalidomide or similar medication.
I am taking more than 2 mg of dexamethasone or its equivalent daily.
I have been diagnosed with plasma cell leukemia.
Treatment Details
The study tests a SVN53-67/M57-KLH peptide vaccine with incomplete Freund's adjuvant plus sargramostim in patients on lenalidomide maintenance therapy. The goal is to see if this combination can stimulate an immune response that targets cancer cells expressing survivin.
2Treatment groups
Experimental Treatment
Group I: Group B (vaccine and week-0 lenalidomide maintenance therapy)Experimental Treatment5 Interventions
Patients receive SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant SC and sargramostim SC every 2 weeks at weeks 4, 6, 8, and 10 for up to 4 doses and then receive a booster in week 16. Beginning in week 0, patients receive lenalidomide maintenance therapy PO QD in the absence of disease progression or unacceptable toxicity.
Group II: Group A (vaccine and week-4 lenalidomide maintenance therapy)Experimental Treatment5 Interventions
Patients receive SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant SC and sargramostim SC every 2 weeks at weeks 0, 2, 4, and 6 for up to 4 doses and then receive a booster in week 12. Beginning in week 4, patients receive lenalidomide maintenance therapy PO QD in the absence of disease progression or unacceptable toxicity.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Roswell Park Cancer InstituteBuffalo, NY
University of Rochester Medical CenterRochester, NY
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Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
CelgeneIndustry Sponsor