²¹¹At-OKT10-B10 with Fludarabine
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
What will happen during the trial?
OUTLINE: This is a dose-escalation study of ²¹¹At-OKT10-B10. Patients are assigned to 1 of 2 arms.
ARM A: Patients with HLA-matched related or unrelated donors receive ²¹¹At-OKT10-B10 intravenously (IV) on day -7 (day -10 to -5) and fludarabine IV over 30 minutes on days -4 to -2. Patients then undergo TBI and allogeneic HCT on day 0. Additionally, patients undergo x-rays on study, and blood sample collection, bone marrow biopsy, and bone marrow aspiration throughout the study.
ARM B: Patients with HLA-matched haploidentical donors receive ²¹¹At-OKT10-B10 IV on day -8 (day -14 to -7), fludarabine IV over 30 minutes on days -6 to -2, and cyclophosphamide IV over 1 hour on day -6 and -5. Patients then undergo TBI on day -1 and allogeneic HCT on day 0. Additionally, patients undergo x-rays on study, and blood sample collection, bone marrow biopsy, and bone marrow aspiration throughout the study.
After completion of study treatment, patients are followed up at 9, 12, 18 and 24 months.
More Information
- Trial Status
- Not yet accepting
- Trial Phase
- Phase 1
- Enrollment
- 30 patients (estimated)
- Sponsors
- Fred Hutchinson Cancer Research Center
- Collaborators
- National Cancer Institute (NCI)
- Tags
- Monoclonal Antibody, Allogeneic Stem Cell Transplant, CD38, High Risk
- Trial Type
- Treatment
- Last Update
- SparkCures ID
- 1138
- NCT Identifier
- NCT04579523
Real People. Real Support.
Need help connecting with this clinical trial? We're here to help!
Print this trial to share with your doctor.
We can help answer any questions and connect you (or your patient) with the study team.
Schedule a time that is convenient and we’ll call you to see how we can help you and your patient.