This phase I/II trial tests the safety, side effects, and best dose and whether a cancer vaccine, called CVD908ssb-TXSVN, work to shrink tumors in patients with multiple myeloma. TXSVN is a weakened form of a live vaccine made from the Salmonella bacteria (Salmonella is a bacterial infection of the intestinal tract). It has been changed in the laboratory to produce a protein called Survivin , but at a lower dose than doses given to healthy volunteers. TXSVN may activate the immune system, which is the body's ability to fight disease, and help develop a response against cancer cells that express Survivin.
Additional locations may be listed on ClinicalTrials.gov for NCT03762291.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE :
I. To evaluate the safety of a live oral attenuated survivin-expressing CVD908ssb-TXSVN Vaccine (CVD908ssb-TXSVN) vaccine in patients with multiple myeloma.
SECONDARY OBJECTIVE:
I. To evaluate antitumor efficacy of oral attenuated CVD908ssb-TXSVN vaccine in patients with multiple myeloma.
EXPLORATORY OBJECTIVE:
I. To evaluate the immunogenicity of CVD908ssb-TXSVN vaccine in patients with multiple myeloma.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II dose escalation study.
Patients receive CVD908ssb-TXSVN orally (PO) on days 0 and 14 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3, 6, 9 and 12 months and then annually for up to 4 additional years (total of 5 years).
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorPremal Lulla
