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

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Roswell Park Cancer Institute
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Celgene
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT02334865
First received: January 6, 2015
Last updated: February 24, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Partial Response of Multiple Myeloma or Plasma Cell Leukemia Plasma Cell Myeloma Biological: Incomplete Freund's Adjuvant Other: Laboratory Biomarker Analysis Drug: Lenalidomide Biological: Sargramostim Biological: SVN53-67/M57-KLH Peptide Vaccine Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

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 [ 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:
  • 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.


Estimated Enrollment: 18
Actual Study Start Date: March 9, 2016
Estimated Study Completion Date: November 9, 2019
Estimated Primary Completion Date: November 9, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Freund's Incomplete Adjuvant
  • IFA
  • ISA-51
  • Montanide ISA 51
  • Montanide ISA-51
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
Biological: Sargramostim
Given SC
Other Names:
  • 23-L-Leucinecolony-Stimulating Factor 2
  • DRG-0012
  • Leukine
  • Prokine
  • rhu GM-CFS
  • Sagramostim
  • Sargramostatin
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 Names:
  • Freund's Incomplete Adjuvant
  • IFA
  • ISA-51
  • Montanide ISA 51
  • Montanide ISA-51
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Lenalidomide
Given PO
Other Names:
  • CC-5013
  • CC5013
  • CDC 501
  • Revlimid
Biological: Sargramostim
Given SC
Other Names:
  • 23-L-Leucinecolony-Stimulating Factor 2
  • DRG-0012
  • Leukine
  • Prokine
  • rhu GM-CFS
  • Sagramostim
  • Sargramostatin
Biological: SVN53-67/M57-KLH Peptide Vaccine
Given SC

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 =< 2 at study entry
  • Must be free of systemic infection; subjects with active infections (whether or not they require antibiotic therapy) may be eligible after complete resolution of the infection; subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment
  • Absolute neutrophil count >= 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]) =< 3 x upper limit of normal (ULN)
  • All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS)®, and be willing and able to comply with the requirements of the Revlimid REMS®
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program
  • Able to take aspirin (81 or 325 mg) daily for prophylactic anticoagulation (patients intolerant to acetylsalicylic acid, ASA, may use warfarin or low molecular weight heparin)
  • Disease free of prior malignancies for > 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02334865

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Kelvin P. Lee    716-845-4106    kelvin.lee@roswellpark.org   
Principal Investigator: Kelvin P. Lee         
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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 247913 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( US NIH Grant/Contract Award Number )
Study First Received: January 6, 2015
Last Updated: February 24, 2017

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Vaccines
Lenalidomide
Thalidomide
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 26, 2017