Community Study on Belantamab Mafodotin for Relapsed or Resistant Myeloma

Sponsor: Cristiana Costa Chase, DO

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05874193

Provider View

This study is exploring whether the drug belantamab mafodotin, combined with the steroid dexamethasone, can be safely and effectively given to patients with relapsed or resistant multiple myeloma in a community setting. The study will test if giving the drug every 6 weeks is as safe and effective as the usual 3-week schedule.

Patient Parameters

Program Overview

The purpose of this research is to see if belantamab mafodotin, a drug used for treating relapsed or resistant multiple myeloma, can be safely administered in local community settings instead of large medical centers. The study will also test if giving the drug every 6 weeks is as effective and safe as the standard 3-week schedule. Although belantamab mafodotin was removed from the market in 2022 due to mixed results, some patients have shown lasting benefits from the treatment. This study aims to explore these potential benefits further.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of multiple myeloma and have tried at least four previous treatments.
  • The myeloma must not have responded to or must have returned after treatment with specific drugs.
  • Must be in good general health with an ECOG performance status of 0 to 2.
  • Must be 18 years or older.
  • Must have adequate organ function based on specific medical tests.
  • Women must not be pregnant or breastfeeding and must use effective birth control during the study and for 4 months after.
  • Men must agree to use birth control and not donate sperm during the study and for 6 months after.
  • Must not have any severe side effects from previous treatments, except for hair loss.
  • Must be able to understand and agree to the study procedures and provide written consent.
  • Must agree not to wear contact lenses during the study.
  • Must agree to have regular eye exams and use eye drops as directed during the study.

Exclusion Criteria

  • Must not have serious eye problems, except for mild corneal changes.
  • Must not have severe liver or kidney problems.
  • Must not be participating in another clinical trial without permission.
  • Must not have used certain drugs or treatments recently before starting the study.
  • Must not have had major surgery recently.
  • Must not have a history of severe heart problems or uncontrolled high blood pressure.
  • Must not have allergies to the study drugs.
  • Must not have active infections requiring treatment.
  • Must not have HIV unless it is well-controlled.
  • Must not have active hepatitis B or C infections.
  • Must not have other active cancers unless they have been stable for at least 2 years.
  • Must not have any serious medical or psychiatric conditions that could interfere with the study.

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