Smoldering Multiple Myeloma Clinical Trial
Official title:
A Phase 1/2a Dose Escalation Study of PVX-410, a Multi-Peptide Cancer Vaccine, in Patients With Smoldering Multiple Myeloma
Verified date | September 2016 |
Source | OncoPep, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | September 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 95 Years |
Eligibility |
- 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Winship Cancer Institute, Emory University | Atlanta | Georgia |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of Texas, MD Anderson Cancer Center | Houston | Texas |
United States | Illinois Cancer Specialists | Niles | Illinois |
Lead Sponsor | Collaborator |
---|---|
OncoPep, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical Response will be measured. | Clinical response will be determined by the treating physician according to the International Myeloma Working Group Disease Response Criteria. | Designated timepoints during the treatment phase (3 months) and follow up phase (12 months) | No |
Primary | All adverse events will be recorded. | Throughout treatment phase (3 months) and follow up period (12 months) | Yes | |
Secondary | Immune response to the vaccine will be measured | Patient blood samples will be measured for immune response through ELISPOT and Pentamer assays. | Designated timepoints during the treatment phase (3 months) and follow up phase (12 months) | No |
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