Study on Belantamab Mafodotin Alone and with Other Cancer Treatments for Relapsed/Refractory Multiple Myeloma

Sponsor: GlaxoSmithKline

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04126200

Provider View

This clinical trial is testing the effects of a drug called Belantamab Mafodotin, both by itself and in combination with other cancer treatments, for patients with multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study focuses on a drug called Belantamab Mafodotin, which targets a specific protein found on multiple myeloma cells. The trial is in Phase I/II and is open-label, meaning both the researchers and participants know what treatment is being given. The study aims to evaluate how well Belantamab Mafodotin works alone and with other cancer drugs in patients whose multiple myeloma has come back or hasn't responded to previous treatments. The study uses a platform design, allowing multiple treatment combinations to be tested under one main protocol.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of multiple myeloma.
  • Must have had at least three previous treatments for multiple myeloma, including specific types of drugs.
  • If previously had a stem cell transplant, it must have been over 100 days ago and with no active infections.
  • Must have a performance status score of 0-1, or 2 if due to bone issues from multiple myeloma.
  • Must have measurable disease based on specific medical tests.
  • If tested positive for Hepatitis B, certain conditions must be met.
  • Can be on low-dose steroids or certain other types of steroids.

Specific to Sub-studies 6, 7, and 8:

  • Must meet specific contraception requirements.
  • Must have a platelet count of at least 75 x 10^9/L.

Specific to Sub-study 8:

  • In Japan, participants must be Japanese, and in China, participants must be Chinese, based on ancestry.

Exclusion Criteria

  • Have current eye disease, except mild conditions.
  • Have heart-related risks.
  • Have allergies to Belantamab Mafodotin or similar drugs.
  • Have active infections needing treatment.
  • Have used other monoclonal antibodies or anti-myeloma therapy recently.
  • Have had recent radiotherapy or major surgery.
  • Have had certain types of transplants or CAR-T therapy recently.
  • Have received blood transfusions recently.
  • Must not have received live vaccines recently.
  • Have active kidney issues, except proteinuria from multiple myeloma.
  • Have HIV unless under control with treatment.

For Sub-studies 1 and 2:

  • Have autoimmune diseases needing treatment in the past 2 years.
  • Have had recent pericarditis.

For Sub-studies 3, 6, 7, and 8:

  • Have uncontrolled intestinal or skin diseases.
  • Have certain electrolyte imbalances.
  • Have used gamma secretase inhibitors.
  • Are taking strong CYP3A4 inhibitors or inducers.

For Sub-study 4:

  • Have active autoimmune diseases needing treatment recently.
  • Have used certain immune therapies.
  • Have immunodeficiency or are on immunosuppressive therapy.

For Sub-study 5:

  • Have severe allergies to Isatuximab-irfc or its ingredients.
  • Have used other anti-CD38 antibodies recently.
  • Have allergies to certain protein products.

For Sub-studies 6, 7, and 8:

  • Have recent history of blood clots.
  • Have active bleeding issues.
  • Cannot or will not take blood clot prevention measures.

For Sub-studies 6 and 8:

  • Stopped lenalidomide due to side effects.

For Sub-study 7:

  • Stopped pomalidomide due to side effects.

For Sub-study 8:

  • Are pregnant or breastfeeding.
  • Have lung disease or complications.

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