This phase I trial studies the safety of SVN53-67/M57-KLH peptide vaccine in incomplete
Freund's adjuvant together with sargramostim in treating patients with newly diagnosed
multiple myeloma who are receiving lenalidomide maintenance therapy. Vaccines made from
survivin peptide may help the body build an effective immune response to kill cancer cells
that express survivin. Incomplete Freund's adjuvant may help stimulate the body's immune
response to a vaccine treatment. Colony-stimulating factors, such as sargramostim, may
increase the production of blood cells. Lenalidomide may stop the growth of cancer cells by
blocking some of the enzymes needed for cell growth. Giving SVN53-67/M57-KLH peptide vaccine
in incomplete Freund's adjuvant and sargramostim before or after the start of lenalidomide
maintenance therapy may be a better treatment for multiple myeloma.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Inclusion Criteria:
- Understand and voluntarily sign an informed consent form
- 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 >= 1000/mm^3
- Absolute lymphocyte count >= 1000/mm^3
- Platelet count >= 50,000/mm^3
- Creatinine clearance >= 60 mL/minutes
- Total bilirubin =< 1. 5 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)
- 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
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
- 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