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Cancer Vaccine

Cancer Vaccine + Lenalidomide for Multiple Myeloma

Phase 1
Waitlist Available
Led By Jens Hillengass, MD, PhD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All study participants must have one of the HLA alleles: HLA-A*02, HLA-A*03, HLAA*11, or HLA-A*24
Patients with newly diagnosed multiple myeloma who have at least a partial response after induction therapy based on the International Working Group (IWG) Uniform Response Criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks
Awards & highlights

Study Summary

This trial is testing a new cancer vaccine in patients with newly diagnosed multiple myeloma who are receiving lenalidomide maintenance therapy. The vaccine is made from a survivin peptide and is given with sargramostim and incomplete Freund's adjuvant. Colony-stimulating factors like sargramostim increase the production of blood cells. Lenalidomide may stop the growth of cancer cells. Giving the vaccine before or after the start of lenalidomide maintenance therapy may be a better treatment for multiple myeloma.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, flu-like symptoms from the immune response such as fever and chills, fatigue due to increased blood cell production by sargramostim, and typical lenalidomide effects like rash or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have one of the required HLA types for the study.
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My multiple myeloma has partially improved after initial treatment.
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I can take care of myself but might not be able to do heavy physical work.
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I do not have any ongoing infections and haven't taken antibiotics in the last 7 days.
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I agree to follow the pregnancy testing schedule as required.
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I can take aspirin daily or use an alternative anticoagulant if needed.
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I have been cancer-free for over 2 years, except for some skin cancers or early-stage cervical or breast cancer.
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My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Toxicity profile of the SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant plus sargramostim, given before or after the start of lenalidomide maintenance
Secondary outcome measures
Immune response using interferon (IFN)-gamma enzyme-linked immunospot (ELISPOT) and multimer assays

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Sargramostim
2008
Completed Phase 4
~710

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
397 Previous Clinical Trials
30,599 Total Patients Enrolled
20 Trials studying Multiple Myeloma
2,082 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
632 Previous Clinical Trials
127,902 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,845 Patients Enrolled for Multiple Myeloma
Jens Hillengass, MD, PhDPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Multiple Myeloma
15 Patients Enrolled for Multiple Myeloma

Media Library

SVN53-67/M57-KLH Peptide Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02334865 — Phase 1
Multiple Myeloma Research Study Groups: Group A (vaccine and week-4 lenalidomide maintenance therapy), Group B (vaccine and week-0 lenalidomide maintenance therapy)
Multiple Myeloma Clinical Trial 2023: SVN53-67/M57-KLH Peptide Vaccine Highlights & Side Effects. Trial Name: NCT02334865 — Phase 1
SVN53-67/M57-KLH Peptide Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02334865 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this investigation?

"Evident from clinicaltrials.gov, the recruitment period for this trial has ended as it was first posted in April 2017 and last updated in June 2022. Nevertheless, there are over a thousand other trials at present actively recruiting patients."

Answered by AI

What kind of adverse effects could patients face from being administered SVN53-67/M57-KLH Peptide Vaccine?

"As SVN53-67/M57-KLH Peptide Vaccine is currently in Phase 1, meaning that the safety and efficacy of this vaccine have only been tested on a small scale, our team at Power assigned it a score of one."

Answered by AI

What medical conditions has the SVN53-67/M57-KLH Peptide Vaccine been found to help alleviate?

"SVN53-67/M57-KLH Peptide Vaccine is a commonly prescribed therapy for radiation syndrome, yet it may also be effective in managing neutropenia, chronic lymphocytic leukemia and certain types of severe infection."

Answered by AI

How many participants are currently taking part in this research?

"This trial has ceased its recruitment of patients, with an initial post date on April 13th 2017 and the last edit made June 21st 2022. For those looking for alternative studies, 819 trials are actively recruiting people with leukemia or plasma cell conditions while 310 require participants to participate in a SVN53-67/M57-KLH Peptide Vaccine study."

Answered by AI

What evidence exists concerning the effectiveness of SVN53-67/M57-KLH Peptide Vaccine?

"At present, there are 310 clinical investigations concerning SVN53-67/M57-KLH Peptide Vaccine. Of those running studies, 61 are presently in their third phase of development. Although most trials for this vaccine take place in Chicago, Illinois, 15126 sites across the world have these tests underway."

Answered by AI
~2 spots leftby Mar 2025