Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05789303

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

Led by University of Chicago · Updated on 2025-12-22

83

Participants Needed

1

Research Sites

265 weeks

Total Duration

On this page

Sponsors

U

University of Chicago

Lead Sponsor

G

GlaxoSmithKline

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Life expectancy greater than three months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate organ function based on clinical lab values
  • Female participants must use contraception according to local regulations
  • Male participants must use contraception or abstain from heterosexual intercourse during treatment and for six months after
  • Prior treatment-related toxicities must be Grade 1 or less except alopecia and Grade 2 peripheral neuropathy
  • Ability to understand and agree to study procedures and provide written informed consent
  • Willingness to comply with belantamab mafodotin and pomalidomide Risk Evaluation and Mitigation Strategy (REMS) programs
  • Relapsed or refractory multiple myeloma requiring systemic therapy after two or more prior anti-myeloma treatment lines
  • Prior exposure to lenalidomide, bortezomib, daratumumab, elotuzumab, pomalidomide, and/or carfilzomib allowed
  • If no prior CAR T-cell therapy: refractory to either carfilzomib or pomalidomide but not both
  • If prior CAR T-cell therapy: progression after anti-BCMA targeted CAR T-cell therapy regardless of refractory status
  • Measurable disease indicated by serum M-protein, urine M-protein, or involved serum free light chains meeting specific thresholds
  • Insurance approval for pomalidomide and dexamethasone
Not Eligible

You will not qualify if you...

  • Diagnosis of Waldenström's macroglobulinemia, systemic amyloidosis, POEMS syndrome, or plasma cell leukemia at screening
  • Radiotherapy to multiple sites within 3 weeks before starting treatment (single-site radiotherapy allowed if at least 1 week prior)
  • Use of investigational drugs or approved systemic anti-myeloma therapy within 14 days before first study drug dose
  • Prior refractory status to belantamab mafodotin
  • Current corneal epithelial disease more severe than mild changes or mild punctate keratopathy
  • Unstable liver or biliary disease including ascites, encephalopathy, coagulopathy, hypoalbuminemia, varices, jaundice, or cirrhosis
  • Active renal conditions requiring treatment or dialysis
  • Use of contact lenses during the study unless directed by an ophthalmologist
  • Simultaneous enrollment in any other interventional clinical trial
  • Major surgery within 2 weeks prior to starting treatment
  • Active mucosal or internal bleeding
  • Significant neuropathy (Grade 3-4 or Grade 2 with pain) at or within 14 days before enrollment
  • Cardiovascular risks including uncontrolled arrhythmias, recent serious heart events, severe heart failure, or uncontrolled hypertension
  • Known hypersensitivity to belantamab mafodotin or related drugs
  • Active infection requiring treatment
  • HIV infection without meeting specific clinical criteria
  • Hepatitis B infection without meeting clinical criteria
  • Positive hepatitis C antibody or RNA test unless successfully treated and confirmed negative
  • Other invasive malignancies unless stable for at least 2 years
  • Serious or unstable medical, psychiatric, or lab conditions interfering with safety or study compliance
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Actively Recruiting

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Research Team

C

Clinical Trials Intake

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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