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

NCT01718899 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2016-09-28

No results posted yet for this study

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.

Conditions

  • Smoldering Multiple Myeloma

Interventions

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

Sponsors & Collaborators

  • OncoPep, Inc.

    lead INDUSTRY

Principal Investigators

  • Noopur Raje, MD · Massachusetts General Hospital

  • Michael Wang, MD · M.D. Anderson Cancer Center

  • Ajay Nooka, MD · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-06-30
Completion
2016-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01718899 on ClinicalTrials.gov