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

Q: What medical maladies does Allogeneic Hematopoietic Stem Cell Transplantation commonly seek to alleviate?

<p>Maladies such as <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, mixed-cell type <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a> and acute myelocytic <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> can <a href="https://www.withpower.com/clinical-trials/all">all</a> be remedied with Allogeneic Hematopoietic Stem Cell Transplantation.</p>

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

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 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.

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

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 more

Trial 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

~3780

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,215 Total Patients Enrolled

64 Trials studying Multiple Myeloma

2,944 Patients Enrolled for Multiple Myeloma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,123 Total Patients Enrolled

578 Trials studying Multiple Myeloma

188,700 Patients Enrolled for Multiple Myeloma

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,238 Total Patients Enrolled

66 Trials studying Multiple Myeloma

3,765 Patients Enrolled for Multiple Myeloma

Media Library

Allogeneic Hematopoietic Stem Cell Transplantation Clinical Trial Eligibility Overview. Trial Name: NCT04579523 — Phase 1

Multiple Myeloma Research Study Groups: Arm B (²¹¹At-OKT10-B10, chemotherapy, TBI, HCT), Arm A (²¹¹At-OKT10-B10, fludarabine, TBI, HCT)

Multiple Myeloma Clinical Trial 2023: Allogeneic Hematopoietic Stem Cell Transplantation Highlights & Side Effects. Trial Name: NCT04579523 — Phase 1

Allogeneic Hematopoietic Stem Cell Transplantation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04579523 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any past investigations that have utilized Allogeneic Hematopoietic Stem Cell Transplantation?

"Presently, 889 research initiatives are underway for Allogeneic Hematopoietic Stem Cell Transplantation, with 161 of them in the final stage. Although Philadelphia is home to many studies on this treatment topic, there are 28446 other places running similar investigations."

Answered by AI

Are there still openings for participants in this trial?

"Clinicaltrials.gov does not indicate that this medical study is currently accepting patients. It was initially posted on May 1st of 2023 and its last update occurred in November 16th 2022; nevertheless, there are 1707 other clinical trials recruiting at present."

Answered by AI

How many participants are being studied for this medical experiment?

"Unfortunately, this trial is not currently enrolling patients. Originally posted on May 1st 2023 and last updated on November 16th 2022, it has since been closed off. However, if you are seeking alternative studies in the same field of research there are 818 trials actively recruiting for refractory plasma cell myeloma and another 889 searching for participants to undergo Allogeneic Hematopoietic Stem Cell Transplantation."

Answered by AI

To what extent is Allogeneic Hematopoietic Stem Cell Transplantation a viable therapeutic option for those seeking treatment?

"Out of 3, the safety rating given to Allogeneic Hematopoietic Stem Cell Transplantation is 1 due to its Phase 1 status. Thus far, there have been insignificant amounts of data that validate both this treatment's efficacy and security."

Answered by AI

What kind of subjects is this clinical trial recruiting for participation?

"The parameters of eligibility for this trial are a diagnosis of refractory plasma cell myeloma and an age between 18-70. Currently, the research team is seeking to recruit approximately 30 participants."

Answered by AI

Does the eligibility criteria for this research encompass individuals over sixty years of age?

"To be eligible for the trial, individuals must lie within the age range of 18 to 70 years old."

Answered by AI

What medical maladies does Allogeneic Hematopoietic Stem Cell Transplantation commonly seek to alleviate?

"Maladies such as multiple sclerosis, mixed-cell type lymphoma and acute myelocytic leukemia can all be remedied with Allogeneic Hematopoietic Stem Cell Transplantation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04579523.

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