New vaccine aims to train immune system against myeloma
NCT ID NCT02334865
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether a vaccine made from a protein called survivin can safely boost the immune system to fight multiple myeloma. The study involves 18 patients who have already responded to initial treatment and are taking lenalidomide as maintenance therapy. The vaccine is given with an immune booster (sargramostim) and an adjuvant to strengthen the body's response. The main goal is to check for side effects and see if the vaccine triggers an immune reaction against cancer cells.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
18 people
The number who actually took part.
- Started
-
Apr 2017
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Able to adhere to the study visit schedule and other protocol requirements * Patients with newly diagnosed multiple myeloma who have at least a partial response after induction therapy based on the International Working Group (IWG) Uniform Response Criteria * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 at study entry * Must be free of systemic infection; subjects with active infections (whether or not they require antibiotic therapy) may be eligible after complete resolution of the infection; subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatment * Absolute neutrophil count \>= 750/mm\^3 * Platelet count \>= 30,000/mm\^3 * Creatinine clearance \>= 30 mL/minutes * Total bilirubin =\< 2 mg/dL * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x upper limit of normal (ULN) * All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS)®, and be willing and able to comply with the requirements of the Revlimid REMS® * Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program * Able to take aspirin (81 or 325 mg) daily for prophylactic anticoagulation (patients intolerant to acetylsalicylic acid, ASA, may use warfarin or low molecular weight heparin or other anticoagulants as deemed appropriate by physician) * Disease free of prior malignancies for \> 2 years with exception of currently treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast * All study participants must have one of the HLA alleles: HLA-A\*02, HLA-A\*03, HLAA\*11, or HLA-A\*24 * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * Pregnant or breast feeding females; (lactating females must agree not to breast feed while taking lenalidomide) * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study as determined by the Principal Investigator * Chemotherapy, immunotherapy, radiotherapy, radiosurgery, interferon (e.g. Intron-A®), allergy desensitization injections, growth factors (e.g. Procrit®, Aranesp®, Neulasta®), interleukins (e.g. Proleukin®) or any investigational therapeutic medication within 4 weeks of study entry * Known hypersensitivity to thalidomide, lenalidomide, Keyhole Limpet Hemocyanin (KLH), or granulocyte colony-macrophage stimulating factor (GM-CSF) * The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs * Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); patients who are seropositive because of hepatitis B virus vaccine are eligible * Any prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy or autoimmune disorders with visceral involvement * Patients with a known diagnosis of plasma cell leukemia * Systemic corticosteroid therapy \> 2 mg of dexamethasone or equivalent per day at study entry * Patients had prior autologous or allogeneic stem cell transplant; prior stem cell collection is allowed * Life expectancy less than 4 months
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Partial response of multiple myeloma or plasma cell leukemia are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
-
University of Rochester Medical Center
Rochester, New York, 14642, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A clinical study of CS1-Targeted CAR-T cells in Relapsed/Refractory multiple myeloma
- Can a cancer drug's real-world performance match clinical trial results?
- Can a maintenance drug keep myeloma at bay?
- New hope for frail myeloma patients: phase III trial tests smarter drug combos
- Could a tiny dose of radiation ease myeloma bone pain?
- Could a common allergy pill ease bone pain in myeloma treatment?