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

September 26, 2016 updated by: OncoPep, Inc.

A Phase 1/2a Dose Escalation Study of PVX-410, a Multi-Peptide Cancer Vaccine, in Patients With Smoldering Multiple Myeloma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute, Emory University
    • Illinois
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas, MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Revlimid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All adverse events will be recorded.
Time Frame: Throughout treatment phase (3 months) and follow up period (12 months)
Throughout treatment phase (3 months) and follow up period (12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Designated timepoints during the treatment phase (3 months) and follow up phase (12 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Designated timepoints during the treatment phase (3 months) and follow up phase (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OncoPep, Inc.

Investigators

  • Principal Investigator: Michael Wang, MD, M.D. Anderson Cancer Center
  • Principal Investigator: Ajay Nooka, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (ESTIMATE)

October 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 26, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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