Interventional Recruiting Phase 1/Phase 2
NCT05853965 on ClinicalTrials.gov
Combination Treatment of Belantamab Mafodotin and Venetoclax in Treatment of Relapsed and Refractory t(11;14) Multiple Myeloma
Official title: 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: University Medical Center Hamburg-Eppendorf
- Enrollment: 45 (Estimated)
- Study start: 2023-06-28 (Actual)
- Primary completion: 2027-04-01 (Estimated)
- Study completion: 2028-12-01 (Estimated)
- Allocation: Non-Randomized
- InterventionModel: Sequential
- InterventionModelDescription: Phase I: 3+3 Fibonacci design Phase II: single group
- Masking: None
- PrimaryPurpose: Treatment
Brief 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)
Conditions
- Multiple Myeloma
- Multiple Myeloma in Relapse
Intervention / Treatment
- Drug: Belantamab mafodotin, Venetoclax
Primary Outcome Measures
-
Recommended Phase II dose (RP2D)
(approx. 9 months)
Establishment of Recommended Phase II dose (RP2D), Evaluation of safety profile, including maximum tolerated dose
Countries
Germany
Locations and Investigators
-
Universitaetsklinikum Ulm AöR, Ulm, Germany
- Miriam, Kull
-
Universitaetsklinikum Schleswig-Holstein AöR, Luebeck, Germany
- Niklas, Gebauer
-
Charite Research Organisation GmbH, Berlin, Germany
- Stephan, Bohl
-
Universitaetsmedizin Greifswald KöR, Greifswald, Germany
- William Hermann, Krüger
-
Universitaetsklinikum Heidelberg AöR, Heidelberg, Germany
- Elias Karl, Mai
-
Klinikum Chemnitz gGmbH, Chemnitz, Germany
- Mathias, Hänel
-
University Medical Center Hamburg-Eppendorf, Hamburg, Germany
- Katja, Weisel
Study Officials
- Katja Weisel (Principal Investigator) — Universitätsklinikum Hamburg-Eppendorf