Study of ²¹¹At-OKT10-B10 and Fludarabine Before Stem Cell Transplant for High-Risk Multiple Myeloma
This study is testing a new treatment for high-risk multiple myeloma, whether it's newly diagnosed, has returned (recurrent), or hasn't responded to other treatments (refractory). It's looking at the side effects and best dose of a drug called ²¹¹At-OKT10-B10. This drug is a special antibody (OKT10-B10) that targets cancer cells and delivers a radioactive agent (²¹¹At) to kill them. It's given along with fludarabine, and sometimes with cyclophosphamide and low-dose total-body irradiation (TBI), before a donor stem cell transplant. The study aims to find the highest safe dose of radiation delivered by ²¹¹At-OKT10-B10. Up to 30 patients, aged 18 to 70, with specific high-risk features of multiple myeloma, can join.
- Study design
- This is a dose-escalation study, meaning the dose of ²¹¹At-OKT10-B10 will be gradually increased to find the safest and most effective amount. Patients will be assigned to one of two groups based on their donor type.
- What's involved
- You would receive ²¹¹At-OKT10-B10, fludarabine, and potentially cyclophosphamide and TBI, followed by an allogeneic hematopoietic stem cell transplant. You would also have X-rays, blood tests, bone marrow biopsies, and bone marrow aspirations throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you would be followed up at 9, 12, 18, and 24 months.
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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
Not Yet Recruiting
PHASE1Ages 18–70InterventionalTreatmentFred Hutchinson Cancer CenterInvestigator-initiated
~30 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Allogeneic Hematopoietic Stem Cell TransplantationAstatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10CyclophosphamideFludarabine PhosphateTotal-Body IrradiationBiospecimen Collection
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD) of radiation delivered via ²¹¹At-OKT10-B10
Measured over Up to 100 days following HCT
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Phuong Vo · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
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
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/or National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) or bone marrow donation, as follows:
Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1. Phenotypic identity must be confirmed by high-resolution typing
Unrelated donor:
Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR
Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing
Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT. If the PRA shows \> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\*0101 and the donor is A\*0102, and this type of mismatch is not allowed
Patients without an HLA-matched related or unrelated donor available must have a related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches
Exclusion
History of central nervous system involvement by multiple myeloma
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
Prior allogeneic HCT
More than two prior autologous HCTs
Patients with plasmacytomas \> 1 cm in bone marrow or any extramedullary plasmacytoma. Previously fludeoxyglucose F-18 (FDG) avid mass lesions by positron emission tomography (PET) that are no longer hypermetabolic following the most recent cycle of therapy are exempt, as are plasmacytomas irradiated with curative intent (\>= 35 Gy)
Patients with symptomatic coronary artery disease defined as having angina or anginal equivalent, and/or arrhythmias requiring anti-arrhythmics for rhythm control
History of reactive airway disease and clinically significant asthma requiring ongoing treatment
Patients with the following organ dysfunction:
Left ventricular ejection fraction \< 40% in patients with HLA-matched or unrelated donor or \< 45% in patients with an HLA-haploidentical donor
New York Heart Association (NYHA) class \> 1 heart failure
Corrected diffusing capacity of the lungs for carbon monoxide (DLCO) \< 50% or receiving supplemental continuous oxygen. When pulmonary function tests cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \< 90% during a 6MWT will be excluded
Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease
Patients who are known to be seropositive for human immunodeficiency virus (HIV)
Perceived inability to tolerate diagnostic or therapeutic procedures
Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin \[HCG\]+) or breast feeding
Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant
Uncontrolled or untreated active infection
Patients with known AL subtype amyloidosis
Inability to understand or give an informed consent
Known allergy to murine-based monoclonal antibodies
Known contraindications to radiotherapy
History of another primary malignancy that has not been in remission for at least 2 years. The following are exempt from the 2-year-limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, or cervical carcinoma in situ or squamous intraepithelial lesion on papanicolaou (PAP) smear
Therapy with anti-CD38 monoclonal antibody within 3 months of ²¹¹At-OKT10-B10 infusion
Prior therapy with radiolabeled monoclonal antibodies
Any history of treatment with checkpoint inhibitor/s
What this trial measures
- Maximum tolerated dose (MTD) of radiation delivered via ²¹¹At-OKT10-B10Up to 100 days following HCT
MTD is defined as the dose of ²¹¹At-OKT10-B10 associated with a true dose limiting toxicity (DLT) rate of 25%, where DLT is defined as grade III/IV regimen-related toxicity according to the Bearman Scale.