Study on Belantamab Mafodotin and Lenalidomide for Treating Multiple Myeloma After Stem Cell Transplant

Sponsor: Roswell Park Cancer Institute

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04876248

Provider View

This clinical trial is exploring the effects of combining belantamab mafodotin and lenalidomide to help patients with multiple myeloma who still have minimal residual disease after a stem cell transplant. The study aims to see if this combination can help maintain low levels of cancer cells.

Patient Parameters

Program Overview

This phase II study is testing whether the combination of belantamab mafodotin and lenalidomide can help patients with multiple myeloma who have minimal residual disease after a stem cell transplant. Belantamab mafodotin is a targeted therapy that attaches to specific receptors on cancer cells and delivers a chemotherapy drug to kill them. Lenalidomide is a standard treatment that may help prevent cancer growth. The goal is to see if this combination can help keep the disease at minimal levels.

Description

The main goal of this study is to see if the combination of belantamab mafodotin and lenalidomide can reduce the minimal residual disease (MRD) in patients after six cycles of treatment following a stem cell transplant. The study will also look at how long patients stay free from disease progression and their overall survival.

Patients will receive belantamab mafodotin through an IV for 30 minutes on the first day of each cycle and take lenalidomide pills daily for 28 days. This treatment cycle will repeat every 8 weeks for a total of 6 cycles, as long as the disease does not progress and side effects are manageable.

After finishing the treatment, patients will have follow-up visits at 12 weeks and then periodically for up to 5 years to monitor their health and the effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Have a confirmed diagnosis of multiple myeloma and be eligible for a stem cell transplant.
  • Not have achieved a complete response with minimal residual disease negativity after high-dose chemotherapy.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women must not be pregnant or breastfeeding and must agree to use effective contraception during and after the study.
  • Men must agree to use contraception and not donate sperm during and after the study.
  • Must understand the study and sign a consent form.

Exclusion Criteria

  • Have had active bleeding requiring treatment in the last four weeks.
  • Have significant eye problems, except mild corneal changes.
  • Have had major surgery in the last four weeks.
  • Use contact lenses during the study.
  • Have had plasmapheresis within 7 days before starting the study.
  • Have active kidney problems requiring treatment.
  • Have serious medical or psychiatric conditions that could interfere with the study.
  • Have unstable liver or bile duct disease.
  • Have another cancer unless it has been stable for at least 2 years.
  • Have significant heart problems or uncontrolled high blood pressure.
  • Have allergies to the study drugs.
  • Have active infections requiring treatment.
  • Have HIV or active hepatitis B or C infections.
  • Have poor vision in the worst-seeing eye.
  • Have used an investigational drug recently.
  • Have previously not responded to belantamab mafodotin.
  • Be pregnant or breastfeeding.
  • Be unable or unwilling to follow the study requirements.
  • Have any condition that makes participation unsuitable according to the investigator.

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