RecruitingPhase 1Phase 2NCT05853965

Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory T(11;14) Multiple Myeloma

Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory T(11;14) Multiple Myeloma (Phase I/IIa) the BELI(E)VE-Trial


Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrollment

45 participants

Start Date

Jun 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn about the safety and efficacy of the drug combination belantamab mafodotin and venetoclax, with or without the addition of dexamethasone, in patients with relapsed/refractory multiple myeloma bearing the translocation t(11;14)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — Belantamab Mafodotin (an antibody that targets cancer cells) and Venetoclax (a drug that promotes cancer cell death) — in people with a specific type of multiple myeloma (a blood cancer) that has returned or stopped responding to previous treatments, and that has a specific genetic change called t(11;14). **You may be eligible if...** - You are 18 or older - You have been diagnosed with multiple myeloma that has returned or is not responding to treatment (relapsed/refractory) - Your myeloma has a specific genetic marker called translocation t(11;14), confirmed by genetic testing - You have received at least one prior line of treatment, including a proteasome inhibitor and an immunomodulatory drug - Your disease is still measurable in the blood or urine **You may NOT be eligible if...** - You have serious eye conditions that cannot be managed - You have uncontrolled infections or serious organ problems - You are pregnant or breastfeeding - You have previously been treated with Belantamab Mafodotin or Venetoclax Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBelantamab mafodotin, Venetoclax

Belantamab mafodotin (IV) Venetoclax (PO)


Locations(5)

University Medical Center Hamburg-Eppendorf

Hamburg, Ham, Germany

Klinikum Chemnitz

Chemnitz, Germany

Uniklinik Heidelberg

Heidelberg, Germany

UKSH Lübeck

Lübeck, Germany

Uniklinkum Ulm

Ulm, Germany

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NCT05853965


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