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

NCT01827137 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 12-288
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

WT1 Analog Peptide Vaccine; 12-288; Galinpepimut-S; GPS; Maintenance therapy; Autologous Stem Cell Transplant (ASCT); Wilms Tumor 1; Immunotherapeutic Agent; Post-ASCT maintenance; SLS-001

Outcome Measures

Primary Outcomes (1)

• WT1 T-cell Immune Response (IR) 12-14 Weeks After First GPS Administration (6 x Administrations)

  Number and percentage of participants with CD4 and/or CD8 immune responses against WT1m measured 12-14 weeks after first GPS administration (6 x administrations)

  12 weeks after the initial GPS vaccine (end of first series [GPS x 6 administrations])

Secondary Outcomes (2)

• Progression-free Survival (PFS) From Autologous Stem Cell Transplant (ASCT)

  3 years and 8 months

• Overall Survival (OS) From Autologous Stem Cell Transplant (ASCT)

  3 years and 8 months

Study Arms (1)

Galinpepimut-S + Montanide + GM-CSF

EXPERIMENTAL

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.

Biological: Galinpepimut-S; Biological: GM-CSF; Other: Montanide; Drug: lenalidomide; Drug: bortezomib

Interventions

Galinpepimut-S BIOLOGICAL

Galinpepimut-S admixed with the adjuvant Montanide following specified schedule

Also known as: GPS, SLS-001

Galinpepimut-S + Montanide + GM-CSF

GM-CSF BIOLOGICAL

subcutaneous injection

Also known as: sargramostim

Galinpepimut-S + Montanide + GM-CSF

Montanide OTHER

adjuvant

Galinpepimut-S + Montanide + GM-CSF

lenalidomide DRUG

optional post-ASCT therapy

Also known as: immunomodulatory drugs

Galinpepimut-S + Montanide + GM-CSF

bortezomib DRUG

optional post-ASCT therapy

Also known as: proteasome inhibitor

Galinpepimut-S + Montanide + GM-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sellas Life Sciences Group: lead
• Memorial Sloan Kettering Cancer Center: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• 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

  RESULT

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Multiple Myeloma; Wilms Tumor

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; sargramostim; Monatide (IMS 3015); Lenalidomide; Immunomodulating Agents; Bortezomib; Proteasome Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action

Results Point of Contact

• Title: Dragan Cicic
• Organization: Sellas Life Sciences

info@sellaslife.com

646-200-5278

Study Officials

• Guenther Koehne, MD, PhD

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

  STUDY DIRECTOR

• David J Chung, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 9, 2013
• Study Start: April 1, 2013
• Primary Completion: December 7, 2016
• Study Completion: November 6, 2017
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)