phase 1/2a study of cancer vaccine to treat smoldering multiple myeloma

Conditions: Smoldering Multiple Myeloma

Summary: the purpose of this study is to determine the safety and tolerability of pvx-410, (a cancer vaccine), treatment regimen for patients with smoldering multiple myeloma as a single agent and in combination with lenalidomide.

this is a dose escalation, phase 1/2a study to assess the safety and tolerability of pvx-410, (a multi-peptide cancer vaccine), treatment regimen in patients with smoldering multiple myeloma as a single agent and in combination with lenalidomide.. approximately 22 patients will receive six (6) bi-weekly, subcutaneous injections of pvx-410 for a total of twelve (12) weeks of treatment. safety will be monitored throughout the study. tolerability, immunogenicity and clinical response will also be measured as described in the protocol.

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 \ 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.