Spots Global Cancer Trial Database for Radioimmunotherapy (211At-OKT10-B10) and Chemotherapy (Melphalan) Before Stem Cell Transplantation for the Treatment of Multiple Myeloma

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Trial Identification

Brief Title: Radioimmunotherapy (211At-OKT10-B10) and Chemotherapy (Melphalan) Before Stem Cell Transplantation for the Treatment of Multiple Myeloma

Official Title: A Phase I Trial Evaluating Escalating Doses of 211At-Labeled Anti-CD38 Monoclonal Antibody (211At-OKT10-B10) Combined With Melphalan as Conditioning Prior to Autologous Hematopoietic Cell Transplantation for Patients With Multiple Myeloma

Study ID: NCT04466475

Conditions

Plasma Cell Myeloma

Interventions

Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10

Melphalan

Peripheral Blood Stem Cell Transplantation

Study Description

Brief Summary: This phase I trial studies the side effects and best dose of 211At-OKT10-B10 when given together with melphalan before a stem cell transplantation in treating patients with multiple myeloma. The radioimmunotherapy drug 211At-OKT10-B10 is a monoclonal antibody, called OKT10-B10, linked to a radioactive substance called 211At. OKT10-B10 attaches to CD38 positive cancer cells in a targeted way and delivers 211At to kill them. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving 211At-OKT10-B10 with melphalan before a stem cell transplant may kill more cancer cells.

Detailed Description: OUTLINE: This is a dose-escalation study of 211At-OKT10-B10. Patients receive 211At-OKT10-B10 intravenously (IV) continuously on day -10 to day - 4 (approximately day -7) and melphalan via infusion on day -2. Patients then undergo hematopoietic cell transplantation (HCT) on day 0. After completion of study treatment, patients are followed for 30 days, between 80 and 90 days, at 6, 9, 12, 18, and 24 months, and then annually thereafter.