NCT05789303

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
26mo left

Started May 2023

Typical duration for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
May 2023Jul 2028

First Submitted

Initial submission to the registry

March 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

5.1 years

First QC Date

March 23, 2023

Last Update Submit

December 19, 2025

Conditions

Relapse Multiple MyelomaMultiple Myeloma

Keywords

multiple myeloma

Outcome Measures

Primary Outcomes (2)

  • Rate of Very Good Partial Response (No Prior CAR T-Cell Therapy Cohort)

    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).

    6-24 months

  • Rate of Overall Response (Prior CAR T-Cell Therapy Cohort)

    Prior CAR T-cell therapy cohort: Rate of overall response (ORR) as determined by investigator assessment.

    6-24 months

Secondary Outcomes (5)

  • Overall Response Rate

    6-24 months

  • Minimal Residual Disease Negativity Rate

    6-24 months

  • Progression-Free Survival

    6-24 months

  • Overall Survival Among Participants

    6-24 months

  • Frequency and Severity of Adverse Events (AEs)/ Serious Adverse Events

    6-24 months

Study Arms (2)

Cohort 1: No Prior CAR T-Cell Therapy

EXPERIMENTAL

This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.

Drug: Belantamab mafodotinDrug: CarfilzomibDrug: PomalidomideDrug: Dexamethasone

Cohort 2: Prior CAR T-Cell Therapy

EXPERIMENTAL

This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.

Drug: Belantamab mafodotinDrug: CarfilzomibDrug: PomalidomideDrug: Dexamethasone

Interventions

Belantamab mafodotinDRUG

Cycles 1, 3, 5, 7, etc. (odd numbered cycles): 1.9 mg/kg IV on Day 1 (28-day cycles)

Also known as: Blenrep
Cohort 1: No Prior CAR T-Cell TherapyCohort 2: Prior CAR T-Cell Therapy
CarfilzomibDRUG

Cycle 1: 20 mg/m2 on Day 1, then 56 mg/m2 on Days 8/15 Cycles 2-8: 56 mg/m2 on Days 1/8/15 Cycles 9+: 56 mg/m2 on Days 1/15

Also known as: Kyprolis
Cohort 1: No Prior CAR T-Cell TherapyCohort 2: Prior CAR T-Cell Therapy
PomalidomideDRUG

3 mg Day 1-21 of 28-day Cycle

Also known as: Pomalyst
Cohort 1: No Prior CAR T-Cell TherapyCohort 2: Prior CAR T-Cell Therapy
DexamethasoneDRUG

Cycles 1-4: 40 mg Days 1/8/15/22 Cycles 5+: 20 mg Days 1/8/15/22

Cohort 1: No Prior CAR T-Cell TherapyCohort 2: Prior CAR T-Cell Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Disease Related
  • Waldenström's macroglobulinemia, systemic amyloidosis, POEMS syndrome, or plasma cell leukemia at the time of screening.
  • Radiotherapy to multiple sites within 3 weeks before start of protocol treatment (localized radiotherapy to a single site 1 week before start is permissible).
  • Subject must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days preceding the first dose of study drug.
  • Prior refractory status to belantamab mafodotin. Concurrent Conditions
  • Current corneal epithelial disease except mild changes in corneal epithelium and mild punctate keratopathy.
  • Subject must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.
  • Subject must not use contact lenses while participating in this study unless instructed by an ophthalmologist.
  • Subject must not be simultaneously enrolled in any interventional clinical trial.
  • Subject must not have had major surgery ≤ 2 weeks prior to initiating study treatment.
  • Subject must not have any evidence of active mucosal or internal bleeding.
  • Significant neuropathy (Grades 3-4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment.
  • Subject must not have evidence of cardiovascular risk including any of the following:
  • History of myocardial infarction, acute coronary syndromes, coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.
  • Class III or IV heart failure as defined by the New York Heart Association functional classification system
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

belantamab mafodotincarfilzomibpomalidomideDexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Benjamin Derman, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Intake

CONTACT

1-855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

March 29, 2023

Study Start

May 30, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF

Locations

US(1)