Study on Belantamab Mafodotin, Pomalidomide, and Dexamethasone for Treating High-Risk Myeloma

Sponsor: Emory University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05208307

Provider View

This clinical trial is exploring a new treatment combination of belantamab mafodotin, pomalidomide, and dexamethasone to see if it can effectively treat patients with high-risk myeloma, a type of blood cancer. The study aims to determine if this combination can kill more cancer cells and improve patient outcomes.

Patient Parameters

Program Overview

This study is testing a combination of three drugs—belantamab mafodotin, pomalidomide, and dexamethasone—to treat high-risk myeloma. Belantamab mafodotin is a targeted therapy that attaches to cancer cells and delivers a chemotherapy drug to kill them. Pomalidomide helps stop cancer cells from growing and spreading, while dexamethasone reduces inflammation and is used alongside other cancer treatments. The goal is to see if this combination can effectively kill more cancer cells in patients with high-risk myeloma.

Description

The main goal of this study is to see how well the combination of belantamab mafodotin, pomalidomide, and dexamethasone (BPd) works in treating high-risk myeloma by looking at the complete response rates. Researchers also want to check the safety and how well patients tolerate this treatment. Additionally, they will study the treatment's effect on the cancer environment in the body.

Patients in the study will receive belantamab mafodotin through an IV every other cycle, pomalidomide by mouth daily for 21 days, and dexamethasone by mouth on specific days. Each treatment cycle lasts 28 days and will continue unless the disease progresses or side effects become unacceptable. After finishing the treatment, patients will have follow-up visits every three months.

Eligibility Criteria

Inclusion Criteria

  • Must have undergone a stem cell transplant within a year of myeloma diagnosis and shown at least a partial response.
  • Must have high-risk myeloma, identified by specific genetic markers or conditions like plasma cell leukemia.
  • Must be in good general health with a performance status of 0 to 2.
  • Must be 18 years or older.
  • Must have adequate blood cell counts and organ function based on specific tests.
  • Women must not be pregnant or breastfeeding and must use effective birth control if of childbearing potential.
  • Men must agree to use contraception and not donate sperm during and after the study.
  • Must have resolved any previous treatment-related side effects to a mild level, except for hair loss.
  • Must understand and agree to the study by signing a consent form.

Exclusion Criteria

  • Must not have serious eye conditions, except mild corneal changes.
  • Must not have unstable liver or kidney disease.
  • Must not use contact lenses during the study.
  • Must not be in another clinical trial or have used certain treatments recently.
  • Must not have had major surgery or plasmapheresis recently.
  • Must not have active bleeding or significant heart issues.
  • Must not have allergies to study drugs or similar medications.
  • Must not have active infections or certain viral infections unless controlled.
  • Must not have other serious medical or psychiatric conditions.
  • Must not be pregnant or breastfeeding.
  • Must not have had another cancer within the last five years, except for certain skin or cervical cancers.
  • Must not have known allergies to specific antiviral or steroid medications.
  • Must not have known central nervous system disease.

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