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NCT01827137 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2024-09-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

WT1 T-cell Immune Response (IR) After Completion of All GPS Administrations

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Biological: Galinpepimut-S
    2. Biological: GM-CSF
    3. Other: Montanide
    4. Drug: lenalidomide
    5. Drug: bortezomib
    label
    Galinpepimut-S + Montanide + GM-CSF
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Galinpepimut-S + Montanide + GM-CSF
    description
    Galinpepimut-S admixed with the adjuvant Montanide following specified schedule
    name
    Galinpepimut-S
    other Names
    1. GPS
    2. SLS-001
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Galinpepimut-S + Montanide + GM-CSF
    description
    subcutaneous injection
    name
    GM-CSF
    other Names
    1. sargramostim
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Galinpepimut-S + Montanide + GM-CSF
    description
    adjuvant
    name
    Montanide
    type
    OTHER
  4. arm Group Labels
    1. Galinpepimut-S + Montanide + GM-CSF
    description
    optional post-ASCT therapy
    name
    lenalidomide
    other Names
    1. immunomodulatory drugs
    type
    DRUG
  5. arm Group Labels
    1. Galinpepimut-S + Montanide + GM-CSF
    description
    optional post-ASCT therapy
    name
    bortezomib
    other Names
    1. proteasome inhibitor
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
20
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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)
    measure
    WT1 T-cell Immune Response (IR) 12-14 Weeks After First GPS Administration (6 x Administrations)
    time Frame
    12 weeks after the initial GPS vaccine (end of first series [GPS x 6 administrations])
secondary Outcomes
  1. description
    PFS measured from ASCT to time of myeloma progression (as defined by the International Myeloma Working Group \[IMW\] consensus criteria or subject death.
    measure
    Progression-free Survival (PFS) From Autologous Stem Cell Transplant (ASCT)
    time Frame
    3 years and 8 months
  2. description
    OS measured from time of autologous stem cell transplant (ASCT) to the time of subject death
    measure
    Overall Survival (OS) From Autologous Stem Cell Transplant (ASCT)
    time Frame
    3 years and 8 months
Full study description
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.
Source references
references
  1. citation
    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
    type
    RESULT
see Also Links
  1. label
    Memorial Sloan Kettering Cancer Center
Source notices and limitations
    Discovery and provenance
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        exact text
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      query cond
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice