TheranosticTrials.org

Clinical Trial · NCT04579523

²¹¹At-OKT10-B10 and Fludarabine Alone or in Combination With Cyclophosphamide and Low-Dose TBI Before Donor Stem Cell Transplant for the Treatment of Newly Diagnosed, Recurrent, or Refractory High-Risk Multiple Myeloma

Overview

This phase I trial investigates the side effects and best dose of ²¹¹At-OKT10-B10 when given together with fludarabine, alone or in combination with cyclophosphamide and low-dose total-body irradiation (TBI) before donor stem cell transplant in treating patients with high-risk multiple myeloma that is newly diagnosed, has come back (recurrent), or does not respond to treatment (refractory). ²¹¹At-OKT10-B10 is a monoclonal antibody, called OKT10-B10, linked to a radioactive agent called ²¹¹At. OKT10-B10 attaches to CD38 positive cancer cells in a targeted way and delivers ²¹¹At to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, 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. Radiation therapy such as TBI uses high energy x-rays to kill cancer cells and shrink tumors. Giving ²¹¹At-OKT10-B10 together with chemotherapy and TBI before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells.

Sponsor

Fred Hutchinson Cancer Center

Phase

Phase 1

Contacts

Phuong Vo (CONTACT)

ptvo@fredhutch.org

206-667-2749

Phuong Vo (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04579523

Drug / Compound

OKT10-B10

Isotope(s):
Target(s):
  • CD38
Ligand Class: Antibodies

Eligibility

Inclusion

  • * Patients with newly diagnosed or relapsed/refractory multiple myeloma
  • Patients with multiple myeloma must have at least one of the following high-risk features:
  • t(4;14), t(14;16), t(14;20) or deletion 17p, gain in chromosome 1q (\> 3 copies of CKS1b) by fluorescence in situ hybridization (FISH); hypodiploidy; complex karyotype
  • Plasmablastic morphology
  • Revised International Staging System III

Exclusion

  • * History of central nervous system involvement by multiple myeloma
  • Prior allogeneic HCT
  • More than two prior autologous HCTs
  • Presence of circulating plasma cells in the peripheral blood of 5% or more by flow cytometry or morphology
  • Prior radioimmunotherapy or radiation of \> 20 Gy to pelvis or at maximally tolerated levels to any critical normal organ