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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days after completing therapy

Awards & highlights

Study Summary

This trial is testing a new drug for people with a certain kind of blood cancer that has come back or didn't respond to treatment.

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.Check my eligibility

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.See study design

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.

Select...

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

Select...

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

Select...

My initial diagnosis confirmed I have AL amyloidosis.

Select...

I am over 18 years old.

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,738 Total Patients Enrolled

3 Trials studying Amyloidosis

525 Patients Enrolled for Amyloidosis

GlaxoSmithKlineIndustry Sponsor

4,755 Previous Clinical Trials

8,070,779 Total Patients Enrolled

11 Trials studying Amyloidosis

189 Patients Enrolled for Amyloidosis

Ankit Kansagra, MDPrincipal InvestigatorUT Southwestern Medical Center

Media Library

Belantamab mafodotin (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05145816 — Phase 1 & 2

Amyloidosis Research Study Groups: Cohort (DL +1) for Part 1, Cohort (DL 0) for Part 1, Cohort (DL -3) for Part 1, Cohort Dose Expansion for Part 2, Cohort (DL -1) for Part 1, Cohort (DL -2) for Part 1

Amyloidosis Clinical Trial 2023: Belantamab mafodotin Highlights & Side Effects. Trial Name: NCT05145816 — Phase 1 & 2

Belantamab mafodotin (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05145816 — Phase 1 & 2

Frequently Asked Questions

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

What is the maximum number of participants accepted for this trial?

"This clinical trial is not open to applicants at the moment. It was initially posted on December 1st 2022 and last updated on July 25th 2022. If you are seeking alternative studies, there are 96 medical trials recruiting for amyloidosis patients and 33 drug-based tests that use Belantamab mafodotin every 4 weeks, 6 weeks or 8 weeks in accordance with Part 1 recommended dosages."

Answered by AI

Has research been conducted to evaluate the efficacy of Belantamab mafodotin dosages at 1.9mg/kg or 2.5mg/kg intervals of 4 weeks, 6 weeks and 8 weeks?

"At present, 33 medical studies are in progress evaluating Belantamab mafodotin 1.9mg/kg or 2.5mg/kg every 4 weeks, 6 weeks or 8 weeks as determined by Part 1 recommended dosages with 4 trials being Phase 3 tests. The majority of these investigations take place at Poitiers cedex, Baden-Wuerttemberg although there is a total of 875 sites around the world conducting experiments related to Belantamab mafodotin 1.9mg/kg or 2.5mg/kg every 4 weeks, 6 weeks or 8 weeks as determined by Part"

Answered by AI

Is this an unprecedented research endeavor?

"Currently, 33 active drug trials for Belantamab mafodotin are being conducted across 221 cities and 34 countries. Karyopharm Therapeutics Inc launched the first such trial in 2015, with 518 participants taking part in Phase 1 & 2 of their research. Subsequently, two additional tests have been finalized to date."

Answered by AI

Is the enrollment process for this scientific research still open?

"This clinical trial has stopped admitting participants. It was first posted on December 1st 2022 and last updated July 25th 2022. If you are seeking other research opportunities, there are currently 96 studies recruiting patients with amyloidosis and 33 trials actively looking for volunteers that would receive Belantamab mafodotin at doses of either 1.9mg/kg or 2.5mg/kg every 4 weeks, 6 weeks, or 8 weeks as determined in Part 1."

Answered by AI

What treatment does Belantamab mafodotin 1.9mg/kg or 2.5mg/kg every 4 weeks, 6 weeks or 8 weeks as determined by Part 1 typically provide patients?

"Patients looking for immunomodulation might consider Belantamab mafodotin, which can be prescribed in doses of 1.9mg/kg or 2.5mg/kg at intervals ranging from 4 to 8 weeks based on Part 1 recommended dosages. Furthermore, this medication has been proven effective when treating conditions such as proteasome inhibitor treatment, relapsed or refractory multiple myeloma and anti-cd38 monoclonal antibody therapy."

Answered by AI

What are the principal goals of this research endeavor?

"The 90 day time frame of this trial is aimed to assess Safety and Tolerability, in terms of the number of patients with dose limiting toxicity (Phase 1). Secondary outcomes include measuring Non-Cardiac Organ Response associated with Belantamab mafodotin by Kidney: reduction in proteinuria by ≥ 30% from baseline; or, a reduction in proteinuria < 0.5g/24 hours without renal progressionLiver: 50% decrease in abnormal alkaline phosphatase (ALP) from baseline, Complete Hematological Response normalization as well as Duration of Response for participants who achieve confirmed PR or better. Progressive"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis

Larry Anderson 2024. "Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05145816.

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