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

Phase 1

Completed

• Conditions: Smoldering Multiple Myeloma
• Interventions: Biological: PVX-410

• Registration Number: NCT01718899
• Lead Sponsor: OncoPep, Inc.

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.

Study Timeline

• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-31
• Study Start: 2012-11
• Primary Completion: 2016-06
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PVX-410, .8 mg dose	PVX-410	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.
PVX-410, .4 mg dose	PVX-410	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.
PVX-410 plus lenalidomide	PVX-410	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

Primary Outcome Measures

Name	Time	Method
All adverse events will be recorded.	Throughout treatment phase (3 months) and follow up period (12 months)

Secondary Outcome Measures

Name	Time	Method
Immune response to the vaccine will be measured	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.

Trial Locations

Locations (6)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Winship Cancer Institute, Emory University; 🇺🇸 Atlanta, Georgia, United States

Illinois Cancer Specialists; 🇺🇸 Niles, Illinois, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Texas, MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States