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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by OncoPep, Inc.
Sponsor:
Information provided by (Responsible Party):
OncoPep, Inc.
ClinicalTrials.gov Identifier:
NCT01718899
First received: October 29, 2012
Last updated: May 30, 2014
Last verified: May 2014
  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 as a single agent and in combination with lenalidomide.


Condition Intervention Phase
Smoldering Multiple Myeloma
Biological: 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: 22
Study Start Date: November 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: March 2015 (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.
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

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.

  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
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: NCT01718899

Locations
United States, Georgia
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sharon Curate Ingram    404-778-2164    Sharon.ingram@emory.edu   
Principal Investigator: Ajay Nooka, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Timothy Lens    617-667-9922    tlens@bidmc.harvard.edu   
Sub-Investigator: David Avigan, MD PhD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Arielle Abovich    617-632-3655    ArielleE_abovich@dfci.harvard.edu   
Sub-Investigator: Paul Richardson, MD, PhD         
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Meredith Wilkes    617-643-3503    mwilkes@mgh.harvard.edu   
Principal Investigator: Noopur Raje, MD         
United States, Texas
University of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Adam Naig    713-563-5277    arnaig@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: May 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014