Study on Selinexor Combined with Carfilzomib, Daratumumab, or Pomalidomide for Multiple Myeloma Patients

Sponsor: Hackensack Meridian Health

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04661137

Provider View

This clinical trial is exploring the effectiveness of combining the drug Selinexor with Carfilzomib, Daratumumab, or Pomalidomide in patients with multiple myeloma whose disease has worsened or not responded to current treatments.

Patient Parameters

Program Overview

The study aims to see how well Selinexor works when combined with other drugs like Carfilzomib, Daratumumab, or Pomalidomide in treating multiple myeloma, a type of blood cancer. Patients whose disease has progressed or not responded to their current treatment will be included. They will be grouped based on their current treatment and will continue receiving the study treatment until their disease progresses, they experience severe side effects, or they choose to stop.

Description

This study is testing a new treatment approach for multiple myeloma, a cancer of the blood. It involves using a drug called Selinexor in combination with other drugs like Carfilzomib, Daratumumab, or Pomalidomide. The study is open to patients whose cancer has not responded to these drugs when used alone.

The study will include about 96 patients, divided into different groups based on their previous treatments. Patients will receive the combination treatment in cycles, with each cycle lasting 28 days. The specific treatment plan depends on the group they are in:

  • Arm 1: For patients whose cancer has not responded to Carfilzomib, they will receive Carfilzomib, Dexamethasone, and Selinexor.
  • Arm 2: For patients whose cancer has not responded to Pomalidomide, they will receive Pomalidomide, Dexamethasone, and Selinexor.
  • Exploratory Arm: For patients whose cancer has not responded to Daratumumab, they will receive Daratumumab, Dexamethasone, and Selinexor.

Patients will continue treatment until their disease progresses, they experience side effects that cannot be managed, or they choose to stop. The study will also collect information on how the disease progresses and any other treatments the patients receive.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of multiple myeloma that has worsened or not responded to current treatments.
  • Must have measurable disease, meaning the cancer can be tracked using specific tests.
  • Must have adequate liver and kidney function.
  • Must have adequate blood cell counts.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 3 months after the last treatment.

Exclusion Criteria

  • Have a type of multiple myeloma called smoldering myeloma.
  • Have received other cancer treatments within 2 weeks before starting the study.
  • Have active graft versus host disease after a stem cell transplant.
  • Have a life expectancy of less than 3 months.
  • Have active hepatitis A, B, or C infection.
  • Have uncontrolled medical conditions that could interfere with the study.
  • Have an active infection requiring treatment within 1 week before starting the study.
  • Are pregnant or breastfeeding.
  • Have a body surface area less than 1.4 m2.
  • Have gastrointestinal issues that interfere with swallowing or absorbing the study drug.
  • Are unable or unwilling to take supportive medications as recommended.
  • Have any serious psychiatric or medical conditions that could interfere with the study.
  • Are unwilling or unable to comply with the study requirements.

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