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WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation

NCT01827137 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-09-19

Study results available
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Summary

The purpose of this trial is to assess the immune response after vaccination with a peptide vaccine called galinpepimut-S (or GPS) in a type of blood cancer called multiple myeloma. A protein called WT1 is often present in cancerous cells and GPS can train the immune system to recognize and kill the cancerous cells containing WT1. This study will also assess the safety of GPS, effect on disease, and on survival.

Participants who has undergone autologous stem cell transplant (ASCT) will receive vaccinations with GPS every 2 weeks for 10 weeks (a total of 6 vaccinations). Vaccinations will start 12 to 22 days after ASCT. In the absence of disease progression and if clinically stable after the first 6 vaccinations, participants may continue to receive six more vaccinations every month. The use of post-ASCT maintenance therapy is allowed starting from 3 months after transplant.

Conditions

Interventions

BIOLOGICAL

Galinpepimut-S

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

BIOLOGICAL

GM-CSF

subcutaneous injection

OTHER

Montanide

adjuvant

DRUG

lenalidomide

optional post-ASCT therapy

DRUG

bortezomib

optional post-ASCT therapy

Sponsors & Collaborators

Principal Investigators

  • Guenther Koehne, MD, PhD · Miami Cancer Institute (Baptist Health South Florida) - formerly at MSKCC

  • David J Chung, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-12-07
Completion
2017-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01827137 on ClinicalTrials.gov