NCT04822337

Study of Carfilzomib, Lenalidomide, Dexamethasone and Belantamab Mafodotin in Multiple Myeloma

A Phase I/II Study of Carfilzomib, Lenalidomide, Dexamethasone and the Anti-B-Cell Maturation Antigen (BCMA) Antibody Drug Conjugate Belantamab Mafodotin in Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is being done to learn if the study drug belantamab mafodotin, in combination with other standard medications, can improve multiple myeloma. This study will also help determine what effects, good and/or bad, this combination of study drugs have on subjects and their cancer, and to evaluate the overall response to this study treatment combination.

Detailed description

This is a phase I dose escalation and expansion study in RMM and RRMM followed by a single arm phase II expansion in high risk, NDMM. The phase I portion of the protocol will utilize a standard 3+3 dose escalation design to determine the maximum tolerated dose (MTD) and RP2D of the KRd-belantamab mafodotin combination. The phase II portion of the trial is a two-stage design that will assess the efficacy and safety of the combination in newly diagnosed, high-risk MM patients.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin	Phase I - Chemotherapy multiple agents systemic Phase II - Maximum Tolerated Dose from Phase I

Timeline

• Start date: 2021-05-19
• Primary completion: 2029-04-01
• Completion: 2032-11-01
• First posted: 2021-03-30
• Last updated: 2026-04-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study