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Multiple Myeloma Trial of Orally Administered Salmonella Based Survivin Vaccine
Bu çalışma, multipl miyelom (multiple myeloma; bir kan kanseri türü) olan hastalarda ağızdan alınan, Salmonella temelli survivin aşısı CVD908ssb-TXSVN'yi değerlendirmektedir. Çalışmaya, en az iki basamak standart tedavi almış, 18 yaş ve üzeri miyelom hastaları katılabilmiştir. Çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: 1. Any patient, greater than or equal to 18 yrs old regardless of sex, with a diagnosis of Myeloma after receiving at least two lines of conventional therapy which can include an autologous HSCT. If a patient has received an autologous or syngeneic SCT they must be greater than 90 days post-transplant 2. Patients with life expectancy greater than or equal to 6 weeks. 3. Pulse oximetry of greater than 90% on room air in patients who previously received radiation therapy to the chest. This is not required in patients who have not received radiation therapy to the chest in the past. 4. Patients with a Karnofsky score of greater than or equal to 50 5. Patients with bilirubin less than or equal to 2x upper limit of normal and Hgb greater than or equal to 7.0 (transfusion allowed). 6. AST less than or equal to 3x upper limit of normal. 7. ANC greater than 1000 at the time of vaccination and an ALC greater than 500. 8. Patients with a creatinine less than or equal to 2x upper limit of normal for age. 9. Patients should have been off other investigational therapy for one month prior to entry in this study. 10. Patients should be off anti-bacterial therapy for 14 days prior to vaccination 11. Patients should have been off conventional therapy for at least 1 week prior to entry in this study except immunomodulator drugs 12. Informed consent explained to, understood by and signed by patient. Patient given copy of informed consent. 13. Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation. 14. Ability to swallow medications Exclusion Criteria 1. Severe intercurrent infection. 2. Patients receiving greater than 0.5 mg/kg/day (prednisone equivalent) of systemic corticosteroids 3. Pregnant or breast feeding. 4. Grade II or higher nausea, vomiting or diarrhea. 5. History of allergy to prior vaccination with a Salmonella vaccine 6. HIV infection 7. Unable to tolerate Salmonella directed antibiotics 8. Household contacts who are immunocompromised, pregnant or under 2 years of age.