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Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT01718899
Recruitment Status : Completed
First Posted : October 31, 2012
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
OncoPep, Inc.

Study Description
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Brief Summary:
The purpose of this study is to determine the safety and tolerability of PVX-410, (a cancer vaccine), treatment regimen for patients with smoldering multiple myeloma as a single agent and in combination with lenalidomide.

Condition or disease Intervention/treatment Phase
Smoldering Multiple Myeloma Biological: PVX-410 Phase 1

Detailed Description:
This is a dose escalation, phase 1/2a study to assess the safety and tolerability of PVX-410, (a multi-peptide cancer vaccine), treatment regimen in patients with smoldering multiple myeloma as a single agent and in combination with lenalidomide.. Approximately 22 patients will receive six (6) bi-weekly, subcutaneous injections of PVX-410 for a total of twelve (12) weeks of treatment. Safety will be monitored throughout the study. Tolerability, immunogenicity and clinical response will also be measured as described in the protocol.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Dose Escalation Study of PVX-410, a Multi-Peptide Cancer Vaccine, in Patients With Smoldering Multiple Myeloma
Study Start Date : November 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PVX-410, .4 mg dose
Approximately 3 patients will receive 6, bi-weekly, subcutaneous injections of a .4 mg dose of PVX-410 in combination with an intramuscular injection of Hiltonol (poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months.
 Biological: PVX-410
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of a dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months
Other Name: Revlimid
Experimental: PVX-410, .8 mg dose
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of an .8 mg dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months.
 Biological: PVX-410
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of a dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months
Other Name: Revlimid
Experimental: PVX-410 plus lenalidomide
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of an .8 mg dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will also receive 3 cycles of lenalidomide. Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months
 Biological: PVX-410
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of a dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months
Other Name: Revlimid


Outcome Measures
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Primary Outcome Measures :
  1. All adverse events will be recorded. [ Time Frame: Throughout treatment phase (3 months) and follow up period (12 months) ]

Secondary Outcome Measures :
  1. Immune response to the vaccine will be measured [ Time Frame: Designated timepoints during the treatment phase (3 months) and follow up phase (12 months) ]
    Patient blood samples will be measured for immune response through ELISPOT and Pentamer assays.


Other Outcome Measures:
  1. Clinical Response will be measured. [ Time Frame: Designated timepoints during the treatment phase (3 months) and follow up phase (12 months) ]
    Clinical response will be determined by the treating physician according to the International Myeloma Working Group Disease Response Criteria.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Patient has confirmed clinical diagnosis of SMM according to a definition derived from the International Myeloma Working Group (IMWG) definition: serum M-protein ≥3 g/dL or bone marrow clonal plasma cells (BMPC) greater than or equal to 10%, or both, along with normal organ and marrow function (CRAB) within 4 weeks before baseline.
  • C: Absence of hypercalcemia, evidenced by a calcium <10.5 mg/dL.
  • R: Absence of renal failure, evidenced by a creatinine <2.0 mg/dL or calculated creatinine clearance (using the Modification of Diet in Renal Disease [MDRD] formula) >50 mL/min.
  • A: Absence of anemia, evidenced by a hemoglobin >10 g/dL.
  • B: Absence of lytic bone lesions on standard skeletal survey.
  • Patient is at higher than average risk of progression to active MM, defined as having 2 or more of the following features:
  • Serum monoclonal (M)-protein ≥3 g/dL.
  • BMPC greater than or equal to 10%.
  • Abnormal serum free light chain (FLC) ratio (0.26-1.65).
  • Patient has a life expectancy of greater than 6 months
  • Patient is human leukocyte antigen (HLA)-A2 positive.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Patient has adequate bone marrow function, evidenced by a platelet count ≥75×109/L and an absolute neutrophil count (ANC) ≥1.0×109/L within 2 weeks before baseline.
  • Patient has adequate hepatic function, evidenced by a bilirubin ≤2.0 mg/dL and an alanine transaminase (ALT), and aspartate transaminase (AST) ≤2.5× the upper limit of normal (ULN) within 2 weeks before baseline.
  • If of child-bearing potential, patient agrees to use adequate birth control measures during study participation.
  • If a female of child-bearing potential, patient has negative urine pregnancy test results within 2 weeks before baseline and is not lactating.
  • Patient (or his or her legally accepted representative) has provided written informed consent to participate in the study.

Exclusion Criteria:

  • Patient has symptomatic multiple myeloma, as defined by any of the following:
  • Lytic lesions or pathologic fractures.
  • Anemia (hemoglobin <10 g/dL).
  • Hypercalcemia (corrected serum calcium >11.5 mg/dL).
  • Renal insufficiency (creatinine >2 mg/dL).
  • Other: symptomatic hyperviscosity, amyloidosis.
  • Patient has abnormal cardiac status, evidenced by any of the following:
  • New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).
  • Myocardial infarction within the previous 6 months.
  • Symptomatic cardiac arrhythmia requiring treatment or persisting despite treatment.
  • Patient is receiving any other investigational agent.
  • Patient has a current active infectious disease or positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
  • Patient has a history of or current auto-immune disease.
  • Patient has been vaccinated with live attenuated vaccines within 4 weeks before study vaccination.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718899


Locations
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United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
United States, Texas
University of Texas, MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
OncoPep, Inc.
Investigators
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Principal Investigator: Noopur Raje, MD Massachusetts General Hospital
Principal Investigator: Michael Wang, MD M.D. Anderson Cancer Center
Principal Investigator: Ajay Nooka, MD Emory University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: OncoPep, Inc.
ClinicalTrials.gov Identifier: NCT01718899    
Other Study ID Numbers: 2010-001
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
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
Precancerous Conditions
Hypergammaglobulinemia
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents