Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma

Status: Recruiting
Phase: Phase 1
Diagnosis: Multiple Myeloma
NCT ID: NCT01718899 (View complete trial on
DFCI Protocol ID: 12-014


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.


Conducting Institutions:
Massachusetts General Hospital, Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Noopur Raje, MD, Massachusetts General Hospital

Site-responsible Investigators:
David Avigan, MD, Beth Israel Deaconess Medical Center
Paul Richardson, MD, Dana-Farber Cancer Institute

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

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) >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 >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 a history of a prior malignancy within the past 5 years (excluding resected basal cell carcinoma of the skin or in situ cervical cancer). - 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.
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