Not Yet RecruitingPhase 1

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

United States30 participantsStarted 2026-06-01

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Revised International Staging System III * Plasmablastic morphology * History of primary or secondary plasma cell leukemia * Patients must start ²¹¹At-OKT10-B10 within 40-180 days of autologous stem cell transplant (either as part of their induction, or as salvage) * Patients must have an estimated creatinine clearance greater than 50/ml per minute measured by 24-hour urine collection * Total bilirubin \< 2 times the upper limit of normal * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2 times the upper limit of normal) * Patients must have an Eastern Cooperative Oncology Group (ECOG) =\< 2 or Karnofsky \>= 70 * Patients must have CD38+ myeloma cells as demonstrated by either flow cytometry or immunohistochemistry in most recent bone marrow that had evidence of clonal plasma cells * For patients of childbearing potential, must have a negative urinary pregnancy test on the day of and prior to infusion of ²¹¹At-OKT10-B10 * Ability to provide informed consent * Patients must have an HLA-matched related donor or an HLA-matched unrelated donor who meets standard Fred Hutchinson Cancer Center and/…

What they're measuring

Maximum tolerated dose (MTD) of radiation delivered via ²¹¹At-OKT10-B10

Timeframe: Up to 100 days following HCT

Trial details

NCT IDNCT04579523

SponsorFred Hutchinson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Phuong Vo

206-667-2749 ptvo@fredhutch.org