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Monoclonal Antibody + Chemotherapy + Radiation for Stem Cell Transplant in Multiple Myeloma

Phase 1

Waitlist Available

Led By Sherilyn Tuazon

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Plasmablastic morphology

History of primary or secondary plasma cell leukemia

Must not have

Known contraindications to radiotherapy

Prior radioimmunotherapy or radiation of > 20 Gy to pelvis or at maximally tolerated levels to any critical normal organ

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from transplantation to death or last patient contact, assessed at 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a targeted monoclonal antibody, linked to a radioactive agent, given with chemo and radiation, before stem cell transplant, to treat high-risk myeloma.

Who is the study for?

This trial is for adults with high-risk multiple myeloma, either newly diagnosed or not responding to treatment. Participants must have specific genetic features of the cancer, good organ function, and a matched stem cell donor available. Pregnant women, those unable to consent, and individuals with certain medical conditions or treatments are excluded.

What is being tested?

The trial tests a radioactive antibody (²¹¹At-OKT10-B10) combined with chemotherapy (fludarabine alone or with cyclophosphamide) and low-dose total-body irradiation before a stem cell transplant. The goal is to see how well this regimen kills cancer cells and prepares the body for new healthy blood-forming cells.

What are the potential side effects?

Potential side effects include reactions from the radioactive antibody, typical chemotherapy-related issues like nausea and hair loss, radiation exposure risks such as skin irritation or fatigue, increased infection risk post-transplant, and complications from receiving donor stem cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer cells are plasmablastic in nature.

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I have had plasma cell leukemia before.

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I have been diagnosed with multiple myeloma for the first time or it has returned.

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My myeloma cells are CD38 positive.

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My kidneys filter waste well, as shown by a test.

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I can take care of myself and perform daily activities.

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I have a donor who matches my HLA type for a stem cell or bone marrow transplant.

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My multiple myeloma has high-risk features like specific genetic changes.

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I will start treatment within 40-180 days after my stem cell transplant.

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My condition is classified as stage III according to the Revised International Staging System.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot receive radiotherapy due to health reasons.

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I have received high-dose radiation to my pelvis or a critical organ.

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I do not have severe liver problems.

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My condition is AL subtype amyloidosis.

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I have heart issues like chest pain or irregular heartbeats needing medication.

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My lung function is below 50% or I need extra oxygen.

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I have asthma that needs regular treatment.

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I am not pregnant or breastfeeding.

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I have had more than two stem cell transplants using my own cells.

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I do not have any untreated or uncontrolled infections.

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I am unable to understand or consent to treatment.

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I have had a stem cell transplant from a donor.

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My multiple myeloma has affected my brain or spinal cord.

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My heart failure is classified above NYHA class 1.

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My heart's pumping ability is below the required level for my type of donor.

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I have previously been treated with radiolabeled monoclonal antibodies.

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I have been treated with checkpoint inhibitors before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from allogeneic hematopoietic cell transplantation to disease progression, relapse or death, assessed at 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from allogeneic hematopoietic cell transplantation to disease progression, relapse or death, assessed at 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from allogeneic hematopoietic cell transplantation to disease progression, relapse or death, assessed at 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic radiology procedure

Secondary study objectives

Disease response

Duration of response

Minimal residual disease (MRD)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (²¹¹At-OKT10-B10, chemotherapy, TBI, HCT)Experimental Treatment9 Interventions

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.

Group II: Arm A (²¹¹At-OKT10-B10, fludarabine, TBI, HCT)Experimental Treatment8 Interventions

Patients 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Biopsy

2021

Completed Phase 3

~230

Biospecimen Collection

2004

Completed Phase 3

~2020