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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.

SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy

Clinicaltrials.gov identifier NCT02334865

Recruitment Status Recruiting

First Posted January 8, 2015

Last update posted June 16, 2020

Study Description

Brief summary:

This phase I trial studies the safety of SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant together with sargramostim in treating patients with newly diagnosed multiple myeloma who are receiving lenalidomide maintenance therapy. Vaccines made from survivin peptide may help the body build an effective immune response to kill cancer cells that express survivin. Incomplete Freund's adjuvant may help stimulate the body's immune response to a vaccine treatment. Colony-stimulating factors, such as sargramostim, may increase the production of blood cells. Lenalidomide may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant and sargramostim before or after the start of lenalidomide maintenance therapy may be a better treatment for multiple myeloma.

  • Condition or Disease:Partial Response of Multiple Myeloma or Plasma Cell Leukemia
    Plasma Cell Myeloma
  • Intervention/Treatment: Biological: Incomplete Freund's Adjuvant
    Other: Laboratory Biomarker Analysis
    Drug: Lenalidomide
    Biological: Sargramostim
    Biological: SVN53-67/M57-KLH Peptide Vaccine
  • Phase: Phase 1
Detailed Description

PRIMARY OBJECTIVES: I. To determine the toxicity profile of the SVN53-67/M57-KLH peptide (SVN53-67/M57-KLH peptide vaccine) in Montanide ISA 51 (incomplete Freund's adjuvant) plus GM-CSF (sargramostim) (vaccine), given before or after the start of lenalidomide maintenance in patients with multiple myeloma. SECONDARY OBJECTIVES: I. To measure the immune responses induced by SVN53-67/M57-KLH with Montanide ISA 51 plus GM-CSF, either alone or with lenalidomide maintenance added either before or after the vaccine. TERTIARY OBJECTIVES: I. To collect preliminary data on therapeutic efficacy of this combination against multiple myeloma, including response rate, time to progression and disease progression slope. II. To test if human leukocyte antigen (HLA) types and survivin positivity affect the immune responses induced by SVN53-67/M57-KLH with Montanide ISA 51 plus GM-CSF. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP A: Patients receive SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant subcutaneously (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 orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. GROUP B: 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. After completion of study treatment, patients are followed up at 16, 20, and 24 weeks and then every 3 months for up to 5 years.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 18 participants
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Phase I Study of Safety, Tolerability and Immunological Effects of SVN53-67/M57-KLH in Patients With Multiple Myeloma Receiving Lenalidomide Maintenance Therapy
  • Actual Study Start Date: March 2016
  • Estimated Primary Completion Date: November 2022
  • Estimated Study Completion Date: November 2023
Arms and interventions
Arm Intervention/treatment
Experimental: Group A (vaccine and week-4 lenalidomide maintenance therapy)
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.
Biological: Incomplete Freund's Adjuvant
Given SC

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Lenalidomide
Given PO

Biological: Sargramostim
Given SC

Biological: SVN53-67/M57-KLH Peptide Vaccine
Given SC
Experimental: Group B (vaccine and week-0 lenalidomide maintenance therapy)
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.
Biological: Incomplete Freund's Adjuvant
Given SC

Other: Laboratory Biomarker Analysis
Correlative studies

Drug: Lenalidomide
Given PO

Biological: Sargramostim
Given SC

Biological: SVN53-67/M57-KLH Peptide Vaccine
Given SC
Outcome Measures
  • Primary Outcome Measures: 1. 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 [ Time Frame: Up to 24 weeks ]
    The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be used to evaluate toxicity. The maximum grade of toxicity for each category of interest will be recorded for each patient and the summary results will be tabulated by category and grade. The frequency of toxicities will also be tabulated for the regimen estimated to be the regimen-limiting toxicity.
  • Secondary Outcome Measures: 1. Immune response using interferon (IFN)-gamma enzyme-linked immunospot (ELISPOT) and multimer assays [ Time Frame: Up to 24 weeks ]
    A responder is defined as a patient who has responded in either IFN-gamma ELISPOT or multimer assays. For both the ELISPOT and multimer assays, time course and magnitude of responses will be plotted and data will be treated using mixed-effect modeling. In addition, Kendall's tau-b will be used to determine whether ELISPOT and multimer responses are associated.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Understand and voluntarily sign an informed consent form

- Able to adhere to the study visit schedule and other protocol requirements

- 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

- Eastern Cooperative Oncology Group (ECOG) performance status of == 750/mm^3

- Platelet count >= 30,000/mm^3

- Creatinine clearance >= 30 mL/minutes

- Total bilirubin =< 2 mg/dL - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = 2 years with exception of currently treated
basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma "in situ" of
the cervix or breast

- All study participants must have one of the HLA alleles: HLA-A*02, HLA-A*03, HLAA*11,
or HLA-A*24

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form

- Pregnant or breast feeding females; (lactating females must agree not to breast feed
while taking lenalidomide)

- 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 as determined by the Principal
Investigator

- Chemotherapy, immunotherapy, radiotherapy, radiosurgery, interferon (e.g. Intron-A®),
allergy desensitization injections, growth factors (e.g. Procrit®, Aranesp®,
Neulasta®), interleukins (e.g. Proleukin®) or any investigational therapeutic
medication within 4 weeks of study entry

- Known hypersensitivity to thalidomide, lenalidomide, Keyhole Limpet Hemocyanin (KLH),
or granulocyte colony-macrophage stimulating factor (GM-CSF)

- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs

- Known seropositive for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are
seropositive because of hepatitis B virus vaccine are eligible

- Any prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy or
autoimmune disorders with visceral involvement

- Patients with a known diagnosis of plasma cell leukemia

- Systemic corticosteroid therapy > 2 mg of dexamethasone or equivalent per day at study
entry

- Patients had prior autologous or allogeneic stem cell transplant; prior stem cell
collection is allowed

- Life expectancy less than 4 months

Contacts and Locations
Contacts
Locations

United States, New York
Roswell Park Cancer Institute
Buffalo

United States, New York
University of Rochester Medical Center
Rochester

Sponsors and Collaborators

Roswell Park Cancer Institute

National Cancer Institute (NCI)

Celgene

Investigators

Principal Investigator: Kelvin Lee Roswell Park Cancer Institute

More Information
  • Responsible Party: Roswell Park Cancer Institute
  • ClinicalTrials.gov Identifier: NCT02334865 History of Changes
  • Other Study ID Numbers: I 247913, NCI-2014-02621, I 247913, P30CA016056
  • First Posted: January 8, 2015 Key Record Dates
  • Last Update Posted: June 16, 2020
  • Last Verified: June 2020
  • Additional relevant MeSH terms: Multiple Myeloma
    Neoplasms, Plasma Cell
    Leukemia, Plasma Cell