Study on Daratumumab, Carfilzomib, Pomalidomide, and Dexamethasone for Treating Relapsed and Resistant Multiple Myeloma

Sponsor: Andrew Yee, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04176718

Provider View

This clinical trial is testing a combination of two study drugs, daratumumab and carfilzomib, with two standard drugs, pomalidomide and dexamethasone, to treat multiple myeloma that has returned or is resistant to previous treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment combination for people with multiple myeloma that has come back or is not responding to previous treatments. The treatment includes two study drugs, daratumumab and carfilzomib, and two standard drugs, pomalidomide and dexamethasone. The goal is to see if this combination can help control the disease in patients who have already tried other therapies.

Description

This is a Phase II study involving multiple centers, where researchers are testing a combination of daratumumab, carfilzomib, pomalidomide, and dexamethasone in patients with relapsed or resistant multiple myeloma. Participants must have tried at least one previous treatment and have been treated with both lenalidomide and a proteasome inhibitor before. The study involves screening for eligibility, receiving the study treatment, and attending follow-up visits. A total of 43 participants will be enrolled. It's important to note that the FDA has not yet approved daratumumab and carfilzomib for treating multiple myeloma.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 to 80 years old.
  • Diagnosed with multiple myeloma, with specific protein levels in the blood or urine.
  • Previously treated for relapsed or resistant multiple myeloma, having received at least one prior therapy.
  • Must have tried at least two cycles of lenalidomide and a proteasome inhibitor.
  • Disease must have progressed within 60 days of the last treatment.
  • Adequate blood cell counts and organ function, as determined by specific tests.
  • Able to take daily aspirin or other blood thinners if needed.
  • Must be registered in the Pomalyst REMS program and comply with its requirements.
  • Women of childbearing potential must agree to regular pregnancy testing.
  • Men must agree to use birth control and not donate sperm during the study and for three months after.
  • Able to swallow capsules whole.

Exclusion Criteria

  • Recent chemotherapy or radiotherapy within two weeks before joining the study.
  • Currently receiving other investigational treatments.
  • Last treatment included the combination of carfilzomib, pomalidomide, and dexamethasone.
  • High-dose corticosteroids, except for certain conditions.
  • Pregnant or breastfeeding women.
  • History of other cancers unless treated and disease-free for at least three years, with some exceptions.
  • Certain blood disorders like plasma cell leukemia or amyloidosis.
  • Positive for HIV or active hepatitis B or C infections.
  • Severe nerve damage or allergies to study drugs.
  • Recent stem cell transplant or ongoing immunosuppressive treatment.
  • Significant health issues that could interfere with the study.
  • Major surgery within two weeks before starting the study.
  • Unresolved side effects from previous cancer treatments.

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