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Monoclonal Antibody + Chemotherapy + Radiation for Stem Cell Transplant in Multiple Myeloma
Phase 1
Waitlist Available
Led By Phuong Vo
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from transplantation to death or last patient contact, assessed at 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic radiology procedure
Secondary outcome measures
Disease response
Duration of response
Minimal residual disease (MRD)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (²¹¹At-OKT10-B10, chemotherapy, TBI, HCT)Experimental Treatment5 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.
Group II: Arm A (²¹¹At-OKT10-B10, fludarabine, TBI, HCT)Experimental Treatment4 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Total-Body Irradiation
1997
Completed Phase 3
~1180
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,305 Total Patients Enrolled
64 Trials studying Multiple Myeloma
2,944 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,965,028 Total Patients Enrolled
588 Trials studying Multiple Myeloma
189,431 Patients Enrolled for Multiple Myeloma
Fred Hutchinson Cancer CenterLead Sponsor
558 Previous Clinical Trials
1,345,561 Total Patients Enrolled
66 Trials studying Multiple Myeloma
3,765 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You may not be able to handle medical tests or treatments.I cannot receive radiotherapy due to health reasons.I have received high-dose radiation to my pelvis or a critical organ.My cancer cells are plasmablastic in nature.I have had plasma cell leukemia before.I have been diagnosed with multiple myeloma for the first time or it has returned.I do not have severe liver problems.You have been tested positive for HIV.My condition is AL subtype amyloidosis.You have an allergy to mouse-derived monoclonal antibodies.Your total bilirubin level is less than twice the normal limit.You have 5% or more plasma cells in your blood.I have heart issues like chest pain or irregular heartbeats needing medication.My lung function is below 50% or I need extra oxygen.My myeloma cells are CD38 positive.My kidneys filter waste well, as shown by a test.I have asthma that needs regular treatment.I have had cancer before, but it's been in remission for at least 2 years, except for certain types like nonmelanoma skin cancer.I am not pregnant or breastfeeding.I have had more than two stem cell transplants using my own cells.I do not have any untreated or uncontrolled infections.I can take care of myself and perform daily activities.I have a donor who matches my HLA type for a stem cell or bone marrow transplant.I haven't had anti-CD38 antibody treatment in the last 3 months.My multiple myeloma has high-risk features like specific genetic changes.I will start treatment within 40-180 days after my stem cell transplant.I am unable to understand or consent to treatment.I have plasmacytomas larger than 1 cm or outside the bone marrow, but treated areas are exempt.I have had a stem cell transplant from a donor.My multiple myeloma has affected my brain or spinal cord.My heart failure is classified above NYHA class 1.My heart's pumping ability is below the required level for my type of donor.My condition is classified as stage III according to the Revised International Staging System.I have previously been treated with radiolabeled monoclonal antibodies.Your AST and ALT levels are not more than twice the upper limit of normal.I have been treated with checkpoint inhibitors before.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (²¹¹At-OKT10-B10, chemotherapy, TBI, HCT)
- Group 2: Arm A (²¹¹At-OKT10-B10, fludarabine, TBI, HCT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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