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

NCT ID: NCT01827137

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-11-06

Brief 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.

Detailed Description

This is an early phase clinical study conducted in patients with newly diagnosed high-risk multiple myeloma to examine the effects of vaccination with galinpepimut-S (GPS) on clinical and immunobiological indices. The study is titled "A Pilot Trial of a WT1 Analog Peptide Vaccine (Galinpepimut-S) in Patients With Multiple Myeloma Following Autologous Stem Cell Transplantation" and is designed as a single-arm, single-institution, open-label study. The primary objective is to assess immune response 12 to 14 weeks after administration of GPS in patients with new diagnosed multiple myeloma (MM) following autologous stem cell transplant (ASCT). Secondary objective includes assessing the safety profile, progression-free survival, and overall survival.

Galinpepimut-S (GPS) consists of four WT1-derived peptides which have been chosen to strengthen antigenicity, but also broaden immunogenicity over a wide range of HLA subtypes, being able to stimulate both CD8+ (MHC Class I)- and CD4+ (MHC Class II)-dependent responses. Galinpepimut-S is administered with the adjuvant Montanide and sargramostim (GM-CSF).

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 with immunomodulatory drugs (IMIDs, eg, thalidomide, lenalidomide) or proteasome inhibitors (PSIs, eg, bortezomib) is allowed from 3 months after transplant.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Galinpepimut-S + Montanide + GM-CSF

Galinpepimut-S (GPS) vaccinations are started 12-22 days following autologous stem cell transplantation (ASCT). GPS and Montanide (in a 1 mL emulsion) are administered subcutaneously (s.c.) Q2W on weeks 0, 2, 4, 6, 8, and 10. GM-CSF (70 μg) are administered s.c. one to two days before and on the day of GPS/Montanide administration. Participants whose disease has not progressed and who are clinically stable (no active infection with fevers and no cardiovascular/respiratory compromise) may receive up to 6 additional monthly vaccinations. The use of post-ASCT maintenance therapy is allowed starting 3 months after ASCT.

Group Type: EXPERIMENTAL

Galinpepimut-S

Intervention Type: BIOLOGICAL

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

GM-CSF

Intervention Type: BIOLOGICAL

subcutaneous injection

Montanide

Intervention Type: OTHER

adjuvant

lenalidomide

Intervention Type: DRUG

optional post-ASCT therapy

bortezomib

Intervention Type: DRUG

optional post-ASCT therapy

Interventions

Galinpepimut-S

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

Intervention Type: BIOLOGICAL

GM-CSF

subcutaneous injection

Intervention Type: BIOLOGICAL

Montanide

adjuvant

Intervention Type: OTHER

lenalidomide

optional post-ASCT therapy

Intervention Type: DRUG

bortezomib

optional post-ASCT therapy

Intervention Type: DRUG

Other Intervention Names

GPS; SLS-001; sargramostim; immunomodulatory drugs; proteasome inhibitor

Eligibility Criteria

Inclusion Criteria

• Symptomatic multiple myeloma, ISS stage 1-3 with confirmed diagnosis of multiple myeloma at MSKCC
• Patients must be eligible to undergo autologous stem cell transplantation by standard institutional criteria
• Patients must have documented WT1 positive disease. For purpose of this study, this is defined as detectable presence of WT1 expression by immunohistochemistry or by WT1 transcript via RT-PCR on a bone marrow or other plasma cell-related biopsy specimen prior to autologous stem cell transplantation. Bone marrow or other biopsy specimen from time of diagnosis from patients diagnosed at MSKCC or outside hospital may be requested for assessment of WT1 expression by IHC
• Age > or = to 18 years
• Karnofsky performance status > or = to 50%
• Hematologic parameters:
• Absolute neutrophil count (ANC) > or = to 1,000/μl
• Platelets > 50,000/μl
• Biochemical parameters:
• Total bilirubin < than or = to 2.0 mg/dl
• AST and ALT < than or = to 2.5 x upper limits of normal (ULN)
• Creatinine < than or = to 2.0 mg/dl

Exclusion Criteria

• Pregnant or lactating women
• Patients with active infection requiring systemic antimicrobials
• Patients taking systemic corticosteroids
• Patients with serious unstable medical illness
• Concurrent malignancies

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: collaborator

Sellas Life Sciences Group

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guenther Koehne, MD, PhD

Role: STUDY_DIRECTOR

Miami Cancer Institute (Baptist Health South Florida) - formerly at MSKCC

David J Chung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

References

Koehne G, Devlin S, Korde N, Mailankody S, Landau H, Hassoun H, Lesokhin A, Lendvai N, Chung D, Sarlis N, Giralt S, Landgren O. Galinpepimut-S, a WT1-Targeting Immuno-Oncology Treatment, Induces Specific, Robust and Durable Immune Responses (IRs) in Patients (Pts) with High-Risk (HR) Multiple Myeloma (MM). Clinical Lymphoma, Myeloma and Leukemia 17: S343-S344, 2017

Reference Type: RESULT

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

12-288

Identifier Type: -

Identifier Source: org_study_id