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Multiple MyelomaPhase 1NCT04579523

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

A Phase 1 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10 and Cyclophosphamide in people with Multiple Myeloma and Recurrent Multiple Myeloma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Allogeneic Hematopoietic Stem Cell Transplantation, Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10 and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jun 2027to 31 Dec 2029
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase I Trial Evaluating Escalating Doses of ²¹¹At-Labeled Anti-CD38 Monoclonal Antibody Followed by HLA-Matched or Haploidentical Donor Hematopoietic Cell Transplantation for High-Risk Multiple Myeloma

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.

Read the detailed description

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.

Being tested
Allogeneic Hematopoietic Stem Cell Transplantation, Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10, Cyclophosphamide, Fludarabine Phosphate, Total-Body Irradiation
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery

    Also called Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC

    Undergo HCT

  • Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10Biological

    Also called ²¹¹At-OKT10-B10, [²¹¹At]OKT10-B10, Astatine 211-labeled Anti-CD38 Monoclonal Antibody OKT10-B10, Astatine At 211 Anti-CD38 MoAb OKT10-B10

    Given IV

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida

    Given IV

  • Fludarabine PhosphateDrug

    Also called 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara

    Given IV

  • Total-Body IrradiationRadiation

    Also called SCT_TBI, TBI, Total Body Irradiation, Whole Body Irradiation

    Undergo TBI

  • Biospecimen CollectionProcedure or surgery

    Undergo blood collection

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow aspirate

  • Bone Marrow BiopsyProcedure or surgery

    Undergo bone marrow biopsy

  • X-Ray ImagingProcedure or surgery

    Also called X-RAY

    Undergo chest x-rays

Study groups in NCT04579523
Study groupRoleWhat they receive
Arm A (²¹¹At-OKT10-B10, fludarabine, TBI, HCT)ExperimentalPatients with HLA-matched related or unrelated donors receive ²¹¹At-OKT10-B10 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.
Receives: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Biological: Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10; Drug: Fludarabine Phosphate; Radiation: Total-Body Irradiation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: X-Ray Imaging
Arm B (²¹¹At-OKT10-B10, chemotherapy, TBI, HCT)ExperimentalPatients 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.
Receives: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Biological: Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10; Drug: Cyclophosphamide; Drug: Fludarabine Phosphate; Radiation: Total-Body Irradiation; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: X-Ray Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Up to 100 days following HCT

Secondary outcomes (5)

  1. Disease response

    Definition of disease status will be performed using the established International Myeloma Working Group (IMWG) response criteria for stringent complete response, complete response, partial response (PR) and no response. Relapse is defined per IMWG criteria. The response rates (PR or better) will be estimated along with the exact 95% confidence interval.

    Measured: Between days 70 to 90 post-transplant

  2. Duration of response

    Duration of response will be estimated using Kaplan-Meier methodology.

    Measured: From date of response assessment (days +70-90 following allogeneic HCT) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

  3. Minimal residual disease (MRD)

    MRD will be assessed in the comprehensive response evaluation/restaging. The proportion who achieve MRD will be estimated along with an exact 95% confidence interval.

    Measured: Between days 70 to 90 post-transplant

  4. One-year disease -free survival

    Kaplan-Meier methodology will be used to estimate the 1-year disease-free survival.

    Measured: From allogeneic hematopoietic cell transplantation to disease progression, relapse or death, assessed at 1 year

  5. One-year overall survival (OS)

    Kaplan-Meier methodology will be used to estimate the 1-year OS.

    Measured: From transplantation to death or last patient contact, assessed at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start1 Jun 2027 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Why it stopped: Study withdrawn before opening to accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04579523
Sponsor's protocol ID
RG1121028
Other IDs
NCI-2020-06835, 10467, P01CA078902
Status last verified
Jun 2026
First submitted
23 Sep 2020
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10 and Cyclophosphamide in people with Multiple Myeloma and Recurrent Multiple Myeloma, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of radiation delivered via ²¹¹At-OKT10-B10 (time frame: Up to 100 days following HCT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04579523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

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