Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma
Completed · Phase 1
Conditions studied: Smoldering Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT01718899
- Run by
- OncoPep, Inc.
- People needed
- 22
- Starts
- 2012-11-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2016-09-28
Who can join
Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
- Illinois Cancer Specialists — Niles, Illinois, 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
Full record on ClinicalTrials.gov
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