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Brief Title: A Study of OPD5 Followed by Autologous Stem Cell Transplant for Patients With Relapsed Refractory Multiple Myeloma
Official Title: An Open-label Phase I, Dose Escalation Study of the Safety and Tolerability of OPD5 as Myeloablative Conditioning Regimen Followed by Autologous Stem Cell Transplant (ASCT) for Patients With Relapsed Refractory Multiple Myeloma (RRMM)
Study ID: NCT04918511
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of a single infusion of OPD5 before Autologous Stem Cell Transplant in patients with RRMM. The study will evaluate increasing doses of OPD5 to find the best dose and to assess any side effects. Each patient will be assigned to a dose cohort of 3-6 patients to receive one single dose of OPD5. Each patient will be hospitalized for about 14 days from the OPD5 infusion and then have monthly visits to the clinic for 3 months and then every third month until disease progression or starting new myeloma treatment, maximum up to 2 years.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology, Brno, , Czechia
University Hospital Ostrava, Clinic of Hematooncology, Ostrava, , Czechia
Charles University and General Hospital in Prague, 1st Department of Medicine - Department of Hematology, First Faculty of Medicine, Praha, , Czechia
Name: Sergio Giralt, MD
Affiliation: Memorial Sloan Kettering Cancer Centre, New York City, United States
Role: PRINCIPAL_INVESTIGATOR