What is the mechanism of action of this treatment?

The most common treatments for Amyloidosis, particularly those similar to Belantamab mafodotin, include antibody-drug conjugates and monoclonal antibodies. Belantamab mafodotin targets B cell maturation antigen (BCMA) on plasma cells, delivering cytotoxic agents directly to the malignant cells, thereby reducing the amyloid light chain production that causes organ damage. Other treatments like daratumumab target CD38 on plasma cells, leading to cell death through immune-mediated mechanisms. These treatments are crucial for Amyloidosis patients as they specifically target the abnormal plasma cells responsible for amyloid production, potentially reducing organ damage and improving survival rates.

What side effects are associated with this type of intervention?

Common treatments for amyloidosis, particularly those similar to Belantamab mafodotin (an antibody-drug conjugate targeting BCMA), include monoclonal antibodies and other targeted therapies. Known side effects of these treatments often include neutropenia, respiratory infections, and infusion-related reactions. Specific to Belantamab mafodotin, side effects can include grade ≥3 neutropenia, pneumonia, and other infections. These treatments may also cause fatigue, gastrointestinal distress, and potential severe toxicities such as capillary leak syndrome and hemolytic uremic syndrome.

What prior FDA approvals exist?

Belantamab mafodotin, an antibody-drug conjugate targeting BCMA, was studied for relapsed or refractory AL Amyloidosis. While it has been withdrawn from the U.S. market, other treatments for Amyloidosis include proteasome inhibitors like bortezomib, immunomodulatory drugs such as lenalidomide and pomalidomide, and monoclonal antibodies like daratumumab. These treatments have been approved for their efficacy in targeting plasma cells and reducing amyloid deposits, thereby improving patient outcomes.

What other types of research exist?

Promising novel alternatives to Belantamab mafodotin for Amyloidosis patients in 2024 include: <ol> <li>Selinexor: An oral selective inhibitor of nuclear export, shown to be effective in multiple myeloma.</li> <li></li> </ol> Daratumumab: A monoclonal antibody targeting CD38, used in combination with other agents for relapsed/refractory multiple myeloma. 3. Isatuximab: Another anti-CD38 monoclonal antibody, often combined with pomalidomide and dexamethasone. 4. Carfilzomib: A proteasome inhibitor, used in combination regimens for relapsed/refractory multiple myeloma. 5. Pomalidomide: An immunomodulatory agent, effective in combination with dexamethasone and other drugs.

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Monoclonal Antibodies

Belantamab Mafodotin for AL Amyloidosis

Phase 1 & 2

Recruiting

Led By Ankit Kansagra, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

Failed treatment and/or intolerant/ineligible for above agents

One or more organs impacted by AL Amyloidosis according to consensus guidelines per National Comprehensive Cancer Network (NCCN)Guidelines Version 1.2016

Must not have

Participant must not have current unstable liver or biliary disease

Evidence of significant cardiovascular condition as specified

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days after completing therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Belantamab mafodotin, a drug that targets and kills harmful cells, on patients with Relapsed Refractory AL Amyloidosis who have not responded to other treatments. The drug works by attaching to bad cells and delivering a toxic substance to eliminate them. Belantamab mafodotin is a newly approved treatment for certain types of cancer.

Who is the study for?

Adults over 18 with relapsed or refractory AL Amyloidosis, who have tried multiple treatments including a proteasome inhibitor and stem cell transplant. They must have an ejection fraction >35%, stable heart condition, measurable disease, and adequate organ function. Women of childbearing potential need a negative pregnancy test; men agree to contraception rules. Excludes those with recent major surgery, active infections, unstable health conditions, or hypersensitivity to the drug.

What is being tested?

The trial is testing different doses of Belantamab Mafodotin (1.9mg/kg or 2.5mg/kg) given every 4, 6 or 8 weeks for safety and effectiveness in treating AL Amyloidosis that has come back or hasn't responded to treatment.

What are the potential side effects?

Potential side effects include eye problems like blurry vision (participants cannot wear contact lenses), infusion reactions related to the drug administration process, fatigue, blood disorders such as low platelet counts which can increase bleeding risk.

Eligibility Criteria

Inclusion Criteria

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

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I cannot tolerate or did not respond to previous treatments.

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My AL Amyloidosis affects one or more of my organs.

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I have measurable signs of amyloid light chain amyloidosis.

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I have AL amyloidosis and have tried more than one treatment.

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I have been treated with a proteasome inhibitor, an alkylator, an anti-CD38 antibody, and had a stem cell transplant.

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My initial diagnosis confirmed I have AL amyloidosis.

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I am over 18 years old.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

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

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My liver and bile ducts are currently stable.

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I have a serious heart condition.

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I do not have any current bleeding from my internal organs or mucous membranes.

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I have been treated for active multiple myeloma.

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I have a corneal disease, but it's only a mild condition.

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I do not have any infections that need treatment.

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I am eligible for a stem cell transplant using my own cells.

Select...

I have a history of serious heart rhythm problems but don't have a pacemaker or ICD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days after completing therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days after completing therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days after completing therapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety/Tolerability as measured by number of subjects with dose limiting toxicity (Part 1)

Safety/Tolerability at the recommended Phase II dose of Belantamab Mafodotin, as measured by number of subjects with dose limiting toxicity (Part 2)

Secondary study objectives

Duration of Cardiac Response (DocR) (Phase 2)

Duration of Response (DoR) (Phase 2)

Percentage of participants with Complete Hematological Response (CHR) (Phase 2)

+8 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Cohort Dose Expansion for Part 2Experimental Treatment1 Intervention

Cohort Dose expansion for Part 2: Belantamab mafodotin Dose from1.0 mg/kg to 2.5mg/kg every 4 weeks, 6 weeks, 8 weeks, or 12 weeks as determined by Part 1 recommended dosage calculations.

Group II: Cohort (DL 0) for Part 1Experimental Treatment1 Intervention

Cohort (DL 0) for Starting Dose : 1.9 mg/kg Belantamab mafodotin intravenously every 8 weeks

Group III: Cohort (DL -3) for Part 1Experimental Treatment1 Intervention

Cohort (DL -3) for Dose De-escalation: 1.0 mg/kg Belantamab mafodotin intravenously every 12 weeks

Group IV: Cohort (DL -2) for Part 1Experimental Treatment2 Interventions

Cohort (DL -2) for Dose De-escalation: 1.4 mg/kg Belantamab mafodotin intravenously every 12 weeks

Group V: Cohort (DL -1) for Part 1Experimental Treatment2 Interventions

Cohort (DL -1) for Dose De-escalation : 1.9 mg/kg Belantamab mafodotin intravenously every 12 weeks

Group VI: Cohort (DL +1) for Part 1Experimental Treatment1 Intervention

Cohort (DL +1) for Dose Escalation: 2.5 mg/kg Belantamab mafodotin intravenously every 8 weeks

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Amyloidosis, particularly those similar to Belantamab mafodotin, include antibody-drug conjugates and monoclonal antibodies. Belantamab mafodotin targets B cell maturation antigen (BCMA) on plasma cells, delivering cytotoxic agents directly to the malignant cells, thereby reducing the amyloid light chain production that causes organ damage. Other treatments like daratumumab target CD38 on plasma cells, leading to cell death through immune-mediated mechanisms. These treatments are crucial for Amyloidosis patients as they specifically target the abnormal plasma cells responsible for amyloid production, potentially reducing organ damage and improving survival rates.

Current trends in multiple myeloma management.