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

NCT02334865 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: I 247913NCI-2014-02621
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Partial Response of Multiple Myeloma or Plasma Cell Leukemia; Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (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

  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.

  Up to 24 weeks

Secondary Outcomes (1)

• Immune response using interferon (IFN)-gamma enzyme-linked immunospot (ELISPOT) and multimer assays

  Up to 24 weeks

Study Arms (2)

Group A (vaccine and week-4 lenalidomide maintenance therapy)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis; Drug: Lenalidomide; Biological: Sargramostim; Biological: SVN53-67/M57-KLH Peptide Vaccine

Group B (vaccine and week-0 lenalidomide maintenance therapy)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis; Drug: Lenalidomide; Biological: Sargramostim; Biological: SVN53-67/M57-KLH Peptide Vaccine

Interventions

Incomplete Freund's Adjuvant BIOLOGICAL

Given SC

Also known as: Freund's Incomplete Adjuvant, IFA, ISA-51, Montanide ISA 51, Montanide ISA-51

Group A (vaccine and week-4 lenalidomide maintenance therapy); Group B (vaccine and week-0 lenalidomide maintenance therapy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Group A (vaccine and week-4 lenalidomide maintenance therapy); Group B (vaccine and week-0 lenalidomide maintenance therapy)

Lenalidomide DRUG

Given PO

Also known as: CC-5013, CC5013, CDC 501, Revlimid

Group A (vaccine and week-4 lenalidomide maintenance therapy); Group B (vaccine and week-0 lenalidomide maintenance therapy)

Sargramostim BIOLOGICAL

Given SC

Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin

Group A (vaccine and week-4 lenalidomide maintenance therapy); Group B (vaccine and week-0 lenalidomide maintenance therapy)

SVN53-67/M57-KLH Peptide Vaccine BIOLOGICAL

Given SC

Group A (vaccine and week-4 lenalidomide maintenance therapy); Group B (vaccine and week-0 lenalidomide maintenance therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or other anticoagulants as deemed appropriate by physician)
• 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
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Celgene: collaborator

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Leukemia, Plasma Cell; Multiple Myeloma

Interventions

incomplete Freund's adjuvant; montanide ISA 51; Lenalidomide; sargramostim; Colony-Stimulating Factors

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Plasma Cell; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Jens Hillengass, MD, PhD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: January 8, 2015
• Study Start: April 13, 2017
• Primary Completion: September 16, 2022
• Study Completion (Estimated): May 19, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

US (2)