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Cancer Vaccine

vaccine for Multiple Myeloma

N/A
Waitlist Available
Led By David J Chung, MD, PhD
Research Sponsored by Sellas Life Sciences Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

The purpose of this study is to see if the investigator can help the immune system to work against myeloma through the use/administration of a peptide vaccine (immunotherapy agent) directed against the Wilms Tumor 1 (WT1) protein called galinpepimut-S (or GPS, for brief). Because cancer is produced by the patient's own body, the immune system does not easily recognize and fight cancer cells. The immune system needs to be "trained" to do this; the latter goal is accomplished by using a vaccine consisting of selected fragments of the target antigen, in this case, WT1. This disease has been selected for this study because the WT1 protein is often present in myeloma cells. WT1 is a gene that is involved in the normal development of kidneys and other organs. When the WT1 gene becomes abnormal, it can make proteins involved in the development of cancer, i.e., can acquire the properties of a true "oncogene". This study will determine whether the vaccine against the WT1 antigen (present in malignant plasmacytes) can cause an immune response which is safe, but also able to keep the myeloma from either coming back or progressing.

Eligible Conditions
  • Multiple Myeloma
  • Minimal Residual Disease
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antigen-specific T-cell immune response (IR) - early
Antigen-specific T-cell immune response (IR) - late
Secondary outcome measures
Overall survival (OS)
Progression-free survival (PFS)
Toxicity profile
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: vaccineExperimental Treatment3 Interventions
Galinpepimut-S (GPS) inoculations are started 12-22 d following autologous stem cell transplantation (ASCT). GPS (1.0 ml of emulsion) is given s.c. on weeks 0, 2, 4, 6, 8, & 10 (i.e., x 6). Injection sites are pre-stimulated with Sargramostim (GM-CSF; 70 μg) s.c. on d -2 (± 1 d ) & d 0 of each GPS inoculation. N.B.: during each GPS inoculation, the Sargramostim & GPS are administered to the same anatomical site. Subjects are observed for >/= 30 minutes after vaccination. Non-progressing subjects who are clinically stable (no active infection with fevers & no cardiovascular/respiratory compromise) may receive up to 6 more vaccinations q-month. The use of post-ASCT maintenance therapy with either lenalidomide or bortezomib is allowed starting >/= 3 months after ASCT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Sargramostim
FDA approved

Find a Location

Who is running the clinical trial?

Sellas Life Sciences GroupLead Sponsor
8 Previous Clinical Trials
781 Total Patients Enrolled
Guenther Koehne, MD, PhDStudy DirectorMiami Cancer Institute (Baptist Health South Florida) - formerly at MSKCC
3 Previous Clinical Trials
111 Total Patients Enrolled
David J Chung, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Frequently Asked Questions

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~2 spots leftby Apr 2025