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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

StatusWithdrawn
PhasePhase 1
Started2027-06-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
critical
Study Status, Study Design, Contacts/Locations v29
Withdrawn before enrolling
Trial withdrawn: Study withdrawn before opening to accrual.
Enrollment targetestimated 30→confirmed 0
Study sitescontacts updated at 1 of 1 site
2026-06-02
critical
Study Status v28
Primary completion pushed: 2027-12-31 → 2028-12-31
Completion pushed: 2028-12-31 → 2029-12-31
Start date2026-06-01→2027-06-01
2026-03-11
minor
Study Status v27
Start date2026-03-01→2026-06-01
2025-12-08
minor
Study Status v26
Start date2025-12-01→2026-03-01
2025-09-08
minor
Study Status v25
Start date2025-09-01→2025-12-01
Show 24 earlier versions
2025-06-03
minor
Study Status v24
Start date2025-05-01→2025-09-01
2025-02-10
minor
Study Status v23
Start date2025-02-07→2025-05-01
2024-11-08
minor
Study Status v22
Start date2024-11-01→2025-02-07
2024-10-16
minor
Study Status, Study Description, Conditions, Arms and Interventions, Eligibility v21
InterventionsAllogeneic Hematopoietic Stem Cell Transplantation (Procedure), Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10 (Biological)…→Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10 (Biological)…
Eligibility criteria-6 characters
[...] donor or an HLA-matched unrelated donor who meets standard SeattleFred Hutchinson Cancer Care Alliance (SCCA)Center and/or National Marrow Donor Program (NMDP) or other donor [...]
Study description+382 characters
[...] o -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 rece [...] ents 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.
2024-04-30
minor
Study Status, Contacts/Locations v20
Start date2024-04-05→2024-11-01
Study sitescontacts updated at 1 of 1 site
2024-02-05
minor
Study Status v19
Start date2024-02-01→2024-04-05
2023-11-07
minor
Study Status v18
Start date2023-11-01→2024-02-01
2023-05-02
minor
Study Status v17
Start date2023-05-01→2023-11-01
2022-11-16
minor
Study Status v16
Start date2022-11-01→2023-05-01
2022-06-22
minor
Study Status v15
Start date2022-06-01→2022-11-01
2022-03-01
minor
Study Status v14
Start date2022-02-01→2022-06-01
2021-11-15
minor
2 amendments v12-v13
2 re-verifications since 2021-10-06, no change to tracked fields
2021-09-24
minor
Study Status, Contacts/Locations v11
Start date2021-08-30→2022-02-01
Study sitescontacts updated at 1 of 1 site
2021-07-30
minor
Study Status v10
Start date2021-07-29→2021-08-30
2021-06-29
minor
Study Status v9
Start date2021-06-26→2021-07-29
2021-05-26
minor
Study Status v8
Start date2021-05-26→2021-06-26
2021-04-26
minor
Study Status v7
Start date2021-04-26→2021-05-26
2021-03-26
minor
Study Status v6
Start date2021-03-25→2021-04-26
2021-02-25
minor
Study Status v5
Start date2021-02-25→2021-03-25
2021-01-25
minor
Study Status v4
Start date2021-01-23→2021-02-25
2020-12-23
minor
Study Status v3
Start date2020-12-23→2021-01-23
2020-11-23
minor
Study Status v2
Start date2020-11-21→2020-12-23
2020-10-21
minor
Study Status v1
Start date2020-10-21→2020-11-21
2020-10-05
minor
Original filing
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.
Trial Details
NCT Number NCT04579523
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions Multiple Myeloma, Recurrent Multiple Myeloma, Refractory Multiple Myeloma
Start Date 2027-06-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-11