Study of Belantamab Mafodotin With Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma

Phase 2

Recruiting

• Conditions: Multiple Myeloma; Relapse Multiple Myeloma
• Interventions: Drug: Belantamab mafodotin; Drug: Carfilzomib; Drug: Pomalidomide; Drug: Dexamethasone

• Registration Number: NCT05789303
• Lead Sponsor: University of Chicago

Brief Summary

Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy.

Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.

Detailed Description

Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy.

Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.

The purpose of this research is to gather information on the safety and effectiveness of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone for patients with a history of two or more prior lines of myeloma therapy. This combination is not FDA-approved, although carfilzomib and pomalidomide, are separately FDA-approved agents in combination with dexamethasone.

Study Timeline

• Study First Submitted: 2023-03-23
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-03-29
• Study Start: 2023-05-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2028-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2: Prior CAR T-Cell Therapy	Belantamab mafodotin	This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
Cohort 1: No Prior CAR T-Cell Therapy	Carfilzomib	This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
Cohort 2: Prior CAR T-Cell Therapy	Dexamethasone	This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
Cohort 1: No Prior CAR T-Cell Therapy	Dexamethasone	This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
Cohort 2: Prior CAR T-Cell Therapy	Pomalidomide	This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
Cohort 1: No Prior CAR T-Cell Therapy	Pomalidomide	This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
Cohort 2: Prior CAR T-Cell Therapy	Carfilzomib	This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
Cohort 1: No Prior CAR T-Cell Therapy	Belantamab mafodotin	This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.

Primary Outcome Measures

Name	Time	Method
Rate of Overall Response (Prior CAR T-Cell Therapy Cohort)	6-24 months	Prior CAR T-cell therapy cohort: Rate of overall response (ORR) as determined by investigator assessment.
Rate of Very Good Partial Response (No Prior CAR T-Cell Therapy Cohort)	6-24 months	No prior CAR T-cell therapy cohort: Rate of very good partial response (VGPR) or better after 6 cycles according to the 2016 International Myeloma Working Group (IMWG) Response Criteria by Independent Review Committee (IRC).

Secondary Outcome Measures

Name	Time	Method
Overall Survival Among Participants	6-24 months	Overall survival of participants as determined by investigator assessment.
Frequency and Severity of Adverse Events (AEs)/ Serious Adverse Events	6-24 months	Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by the Common Terminology Criteria for Adverse Events v5.
Overall Response Rate	6-24 months	Overall response rate as determined by the 2016 International Myeloma Working Group (IMWG) Response Criteria by Independent Review Committee (IRC) and investigator assessment.
Minimal Residual Disease Negativity Rate	6-24 months	Minimal Residual Disease (MRD) negativity rate as assessed by next generation sequencing (limit of detection \< 10-5).
Progression-Free Survival	6-24 months	Progression-free survival of participants as determined by investigator assessment.

Trial Locations

Locations (1)

University of Chicago Medicine Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States