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

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Eligibility
18 to 95, Male and Female
Study Type
Treatment
NCD ID
NCT01718899
Protocol IDs
2010-001 (primary)
Study Sponsor
OncoPep, Incorporated

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.

Objectives

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.

Treatment Sites in Georgia


Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

Study Coordinator:
Cathy sharp
404-778-3811

Doctors:

Leonard T. Heffner Jr., MD
Jonathan L. Kaufman MD
Sagar Lonial MD
Ajay K. Nooka MD, MPH