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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

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 criteria

Qualifiers

Subjects must be ≥ 18 years of age.

Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Subjects must voluntarily sign and date an in-formed consent form

Cytogenetics/FISH confirming t(11;14)

Disqualifiers

Subject has received prior Venetoclax and/or anti BCMA treatment.

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.

Participant has had plasmapheresis or radia-tion therapy within 7 days prior to first dose of study treatment

Participant has current corneal epithelial dis-ease except mild changes in corneal epitheli-um

Trial design

Treatments tested in this trial

  • Belantamab mafodotin, Venetoclax

Treatment groups

45 Participants
are divided into 4 treatment groups