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Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory T(11;14) Multiple Myeloma | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT05853965•Universitätsklinikum Hamburg-Eppendorf

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Relapsed and refractory t(11;14) Multiple Myeloma (RRMM)
•1. Subjects must be ≥ 18 years of age.
•2. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
•3. Subjects must voluntarily sign and date an in-formed consent form
•4. Subjects must have had documented multiple myeloma requiring treatment as defined by the criteria below:
•Monoclonal plasma cells in the bone marrow \> 10% and/or presence of a biopsy proven plasmacytoma at some point in their disease history requiring treatment according diag-nostic criteria (IMWG updated criteria 2014, Rajkumar et al. 2014) with measurable dis-ease at screening (serum M-protein \> 500 mg/dL or urine M protein 200 mg/24h, in case of oligosecretory MM serum free light chain \> 10mg/dL and abnormal kap-pa/lambda free light chain ratio)
•5. Cytogenetics/FISH confirming t(11;14)
•6. Prior treatment requirements:
•Prior treatment requirements:
•a. Subjects must have received at least 1 prior treatment line (induction, high-dose, consolidation and maintenance is considered as one treatment line). All patients have to have received at least one proteasome inhibitor and at least one immunomodulatory agent and at least one anti-CD38 monoclonal antibody.
+11 more criteria

Exclusion Criteria

•1. Subject has received prior Venetoclax and/or anti BCMA treatment.
•2. Participant has used an investigational drug or approved systemic anti-myeloma therapy with-in 14 days or five half-lives, whichever is short-er, preceding the first dose of study drug. The only exception is emergency use of a short course of corticosteroids (equivalent of Dexa-methasone 40 mg/day for a maximum of 4 days) up to 7 days before treatment.
•3. Participant has had plasmapheresis or radia-tion therapy within 7 days prior to first dose of study treatment
•4. Participant has current corneal epithelial dis-ease except mild changes in corneal epitheli-um
•5. Participant has current unstable liver or biliary disease
•6. Participant has a presence of active renal con-dition (infection, requirement for dialysis or any other condition that could affect participant's safety).
•7. Participant has had major surgery ≤ 4 weeks prior to initiating study treatment. Kyphoplasty is not considered a major surgery.
•8. Participant must not use contact lenses while participating in this study. Bandage contacts may be prescribed by an eye care professional if needed.
•9. Participant has any evidence of active mucosal or internal bleeding or other gastrointestinal disease that may significantly alter the absorp-tion of oral drugs.
•10. Participant has evidence of cardiovascular risk as defined in the protocol
+25 more criteria

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

Key Dates

Start Date

June 28, 2023

Primary Completion Date

November 1, 2026

Completion Date

December 1, 2026

Last Updated

March 30, 2025

Enrollment

ESTIMATED participants

Conditions

Multiple MyelomaMultiple Myeloma in Relapse

Interventions

Belantamab mafodotin, Venetoclax

DRUG

Contacts

Katja Weisel

CONTACT

+4940741051410 k.weisel@uke.de

Lisa Leypoldt

CONTACT

l.leypoldt@uke.de

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

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