A Phase 1/2 interventional study of Galinpepimut-S and GM-CSF in Multiple Myeloma, sponsored by Sellas Life Sciences Group. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Sellas Life Sciences Group · Phase 1/2, Interventional, and Treatment
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.
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's enrollment of 20 is below the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Sellas Life Sciences Group is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Galinpepimut-S admixed with the adjuvant Montanide following specified schedule
Also known as: GPS, SLS-001
subcutaneous injection
Also known as: sargramostim
adjuvant
optional post-ASCT therapy
Also known as: immunomodulatory drugs
optional post-ASCT therapy
Also known as: proteasome inhibitor
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)
Time frame: 12 weeks after the initial GPS vaccine (end of first series [GPS x 6 administrations])
Progression-free Survival (PFS) From Autologous Stem Cell Transplant (ASCT)
PFS measured from ASCT to time of myeloma progression (as defined by the International Myeloma Working Group \[IMW\] consensus criteria or subject death.
Time frame: 3 years and 8 months
Overall Survival (OS) From Autologous Stem Cell Transplant (ASCT)
OS measured from time of autologous stem cell transplant (ASCT) to the time of subject death
Time frame: 3 years and 8 months
| Milestone | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Started | 20 |
| Completed | 19 |
| Not completed | 1 |
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)
| Participants | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| WT1 T-cell Immune Response (IR) 12-14 Weeks After First GPS Administration (6 x Administrations) | 9 |
PFS measured from ASCT to time of myeloma progression (as defined by the International Myeloma Working Group \[IMW\] consensus criteria or subject death.
| days | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Progression-free Survival (PFS) From Autologous Stem Cell Transplant (ASCT) | 717 (286 to NA) |
OS measured from time of autologous stem cell transplant (ASCT) to the time of subject death
| days | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Overall Survival (OS) From Autologous Stem Cell Transplant (ASCT) | NA (NA to NA) |
Number and percentage of participants with CD4 and/or CD8 immune responses against WT1 measured after all GPS administrations (12 x administrations)
| Participants | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| WT1 T-cell Immune Response (IR) After Completion of All GPS Administrations | 12 |
Collected over 4.5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Galinpepimut-S + Montanide + GM-CSF | 2/20 (10%) | 0/20 (0%) | 20/20 (100%) |
| Event | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| AnemiaBlood and lymphatic system disorders | 20/20 |
| HyperglycemiaMetabolism and nutrition disorders | 20/20 |
| HypoalbuminemiaMetabolism and nutrition disorders | 20/20 |
| Lymphocyte count decreasedInvestigations | 20/20 |
| Neutrophil count decreasedInvestigations | 20/20 |
| Platelet count decreasedInvestigations | 20/20 |
| White blood cell decreasedInvestigations | 20/20 |
| HypocalcemiaMetabolism and nutrition disorders | 19/20 |
| Alanine aminotransferase increasedInvestigations | 14/20 |
| Aspartate aminotransferase increasedInvestigations | 12/20 |
Analysis set
| Age, Continuous(years) | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Median | 61.3 (46 to 72) |
| Sex: Female, Male(Participants) | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Female | 11 |
| Male | 8 |
| Type of myeloma(Participants) | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| IgG | 12 |
| IgA | 4 |
| Light chain | 3 |
| Prior therapies(number of therapies) | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Median | 2 (1 to 3) |
| Post ASCT therapy(Participants) | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| Lenalidomide alone or in combination | 18 |
| Other (bortezomib) | 1 |
| Prior ASCT(Participants) | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| 1 | 17 |
| 2 | 2 |
| Cytogenetics at diagnosis(Participants) | Galinpepimut-S + Montanide + GM-CSF |
|---|---|
| High risk | 15 |
| Average risk | 4 |
Plan to share: No
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Galinpepimut-s · Granulocyte-Macrophage Colony-Stimulating Factor
Sellas Life Sciences Group