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

This study is currently recruiting participants.
Verified July 2013 by OncoPep, Inc.
Sponsor:
Information provided by (Responsible Party):
OncoPep, Inc.
ClinicalTrials.gov Identifier:
NCT01718899
First received: October 29, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Smoldering Multiple Myeloma
Drug: PVX-410
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by OncoPep, Inc.:

Primary Outcome Measures:
  • All adverse events will be recorded. [ Time Frame: Throughout treatment phase (3 months) and follow up period (12 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immune response to the vaccine will be measured [ Time Frame: Designated timepoints during the treatment phase (3 months) and follow up phase (12 months) ] [ Designated as safety issue: No ]
    Patient blood samples will be measured for immune response through ELISPOT and Pentamer assays.


Other Outcome Measures:
  • Clinical Response will be measured. [ Time Frame: Designated timepoints during the treatment phase (3 months) and follow up phase (12 months) ] [ Designated as safety issue: No ]
    Clinical response will be determined by the treating physician according to the International Myeloma Working Group Disease Response Criteria.


Estimated Enrollment: 13
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: PVX-410
A multi-peptide vaccine administered emulsified in Montanide. Vaccine is administered in combination with Hiltonol (Poly ICLC), an adjuvant.
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.
Drug: PVX-410
A multi-peptide vaccine administered emulsified in Montanide. Vaccine is administered in combination with Hiltonol (Poly ICLC), an adjuvant.

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. Approximately 13 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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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) >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 >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 a history of a prior malignancy within the past 5 years (excluding resected basal cell carcinoma of the skin or in situ cervical cancer).
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718899

Locations
United States, Georgia
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Alaina Mitchell    404-778-5747    alaina.r.mitchell@emory.edu   
Principal Investigator: Ajay Nooka, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christine Connolly    617-726-4319    cconnolly@PARTNERS.org   
Principal Investigator: Noopur Raje, MD         
United States, Texas
University of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Martha Anderson    713-792-2860    mdanderson1@mdanderson.org   
Principal Investigator: Michael Wang, MD         
Sponsors and Collaborators
OncoPep, Inc.
Investigators
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

No publications provided

Responsible Party: OncoPep, Inc.
ClinicalTrials.gov Identifier: NCT01718899     History of Changes
Other Study ID Numbers: 2010-001
Study First Received: October 29, 2012
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, 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

ClinicalTrials.gov processed this record on April 17, 2014