Spots Global Cancer Trial Database for Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma
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Trial Identification
Brief Title: Phase 1/2a Study of Cancer Vaccine to Treat Smoldering Multiple Myeloma
Official Title: A Phase 1/2a Dose Escalation Study of PVX-410, a Multi-Peptide Cancer Vaccine, in Patients With Smoldering Multiple Myeloma
Study ID: NCT01718899
Conditions
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Noopur Raje, MD
Affiliation: Massachusetts General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Wang, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Ajay Nooka, MD
Affiliation: Emory University
Role: PRINCIPAL_INVESTIGATOR
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