Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma
Smoldering Multiple Myeloma
About this trial
This is an interventional treatment trial for Smoldering Multiple Myeloma
Eligibility Criteria
- Patient has confirmed clinical diagnosis of SMM according to a definition derived from the International Myeloma Working Group (IMWG) definition: serum M-protein ≥3 g/dL or bone marrow clonal plasma cells (BMPC) greater than or equal to 10%, or both, along with normal organ and marrow function (CRAB) within 4 weeks before baseline.
- C: Absence of hypercalcemia, evidenced by a calcium <10.5 mg/dL.
- R: Absence of renal failure, evidenced by a creatinine <2.0 mg/dL or calculated creatinine clearance (using the Modification of Diet in Renal Disease [MDRD] formula) >50 mL/min.
- A: Absence of anemia, evidenced by a hemoglobin >10 g/dL.
- B: Absence of lytic bone lesions on standard skeletal survey.
- Patient is at higher than average risk of progression to active MM, defined as having 2 or more of the following features:
- Serum monoclonal (M)-protein ≥3 g/dL.
- BMPC greater than or equal to 10%.
- Abnormal serum free light chain (FLC) ratio (0.26-1.65).
- Patient has a life expectancy of greater than 6 months
- Patient is human leukocyte antigen (HLA)-A2 positive.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patient has adequate bone marrow function, evidenced by a platelet count ≥75×109/L and an absolute neutrophil count (ANC) ≥1.0×109/L within 2 weeks before baseline.
- Patient has adequate hepatic function, evidenced by a bilirubin ≤2.0 mg/dL and an alanine transaminase (ALT), and aspartate transaminase (AST) ≤2.5× the upper limit of normal (ULN) within 2 weeks before baseline.
- If of child-bearing potential, patient agrees to use adequate birth control measures during study participation.
- If a female of child-bearing potential, patient has negative urine pregnancy test results within 2 weeks before baseline and is not lactating.
- Patient (or his or her legally accepted representative) has provided written informed consent to participate in the study.
Exclusion Criteria:
- Patient has symptomatic multiple myeloma, as defined by any of the following:
- Lytic lesions or pathologic fractures.
- Anemia (hemoglobin <10 g/dL).
- Hypercalcemia (corrected serum calcium >11.5 mg/dL).
- Renal insufficiency (creatinine >2 mg/dL).
- Other: symptomatic hyperviscosity, amyloidosis.
- Patient has abnormal cardiac status, evidenced by any of the following:
- New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).
- Myocardial infarction within the previous 6 months.
- Symptomatic cardiac arrhythmia requiring treatment or persisting despite treatment.
- Patient is receiving any other investigational agent.
- Patient has a current active infectious disease or positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
- Patient has a history of or current auto-immune disease.
- Patient has been vaccinated with live attenuated vaccines within 4 weeks before study vaccination.
Sites / Locations
- Winship Cancer Institute, Emory University
- Illinois Cancer Specialists
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
- Massachusetts General Hospital
- University of Texas, MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
PVX-410, .4 mg dose
PVX-410, .8 mg dose
PVX-410 plus lenalidomide
Approximately 3 patients will receive 6, bi-weekly, subcutaneous injections of a .4 mg dose of PVX-410 in combination with an intramuscular injection of Hiltonol (poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months.
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of an .8 mg dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months.
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of an .8 mg dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will also receive 3 cycles of lenalidomide. Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months