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

Primary Purpose

Smoldering Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PVX-410
Sponsored by
OncoPep, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoldering Multiple Myeloma

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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.

Sites / Locations

  • Winship Cancer Institute, Emory University
  • Illinois Cancer Specialists
  • Beth Israel Deaconess Medical Center
  • Dana Farber Cancer Institute
  • Massachusetts General Hospital
  • University of Texas, MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PVX-410, .4 mg dose

PVX-410, .8 mg dose

PVX-410 plus lenalidomide

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

All adverse events will be recorded.

Secondary Outcome Measures

Immune response to the vaccine will be measured
Patient blood samples will be measured for immune response through ELISPOT and Pentamer assays.

Full Information

First Posted
October 29, 2012
Last Updated
September 26, 2016
Sponsor
OncoPep, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01718899
Brief Title
Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma
Official Title
A Phase 1/2a Dose Escalation Study of PVX-410, a Multi-Peptide Cancer Vaccine, in Patients With Smoldering Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OncoPep, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoldering Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVX-410, .4 mg dose
Arm Type
Experimental
Arm Description
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.
Arm Title
PVX-410, .8 mg dose
Arm Type
Experimental
Arm Description
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.
Arm Title
PVX-410 plus lenalidomide
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
PVX-410
Other Intervention Name(s)
Revlimid
Intervention Description
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
Primary Outcome Measure Information:
Title
All adverse events will be recorded.
Time Frame
Throughout treatment phase (3 months) and follow up period (12 months)
Secondary Outcome Measure Information:
Title
Immune response to the vaccine will be measured
Description
Patient blood samples will be measured for immune response through ELISPOT and Pentamer assays.
Time Frame
Designated timepoints during the treatment phase (3 months) and follow up phase (12 months)
Other Pre-specified Outcome Measures:
Title
Clinical Response will be measured.
Description
Clinical response will be determined by the treating physician according to the International Myeloma Working Group Disease Response Criteria.
Time Frame
Designated timepoints during the treatment phase (3 months) and follow up phase (12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noopur Raje, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Wang, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ajay Nooka, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Texas, MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30128502
Citation
Nooka AK, Wang ML, Yee AJ, Kaufman JL, Bae J, Peterkin D, Richardson PG, Raje NS. Assessment of Safety and Immunogenicity of PVX-410 Vaccine With or Without Lenalidomide in Patients With Smoldering Multiple Myeloma: A Nonrandomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):e183267. doi: 10.1001/jamaoncol.2018.3267. Epub 2018 Dec 13.
Results Reference
derived

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

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