Smoldering Multiple Myeloma
Conditions
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALPVX-410
Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of a 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
Sponsors
OncoPep, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All adverse events will be recorded. | Throughout treatment phase (3 months) and follow up period (12 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune response to the vaccine will be measured | Designated timepoints during the treatment phase (3 months) and follow up phase (12 months) | Patient blood samples will be measured for immune response through ELISPOT and Pentamer assays. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response will be measured. | Designated timepoints during the treatment phase (3 months) and follow up phase (12 months) | Clinical response will be determined by the treating physician according to the International Myeloma Working Group Disease Response Criteria. |
Countries
United States
Outcome results
None listed