Study on Selinexor, Pomalidomide, and Dexamethasone With or Without Carfilzomib for Treating Relapsed Refractory Multiple Myeloma (SCOPE Trial)

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04764942

Provider View

This clinical trial is testing a combination of drugs, including selinexor, pomalidomide, and dexamethasone, with or without carfilzomib, to treat patients with multiple myeloma that has returned and is not responding to standard treatments.

Patient Parameters

Program Overview

The purpose of this study is to find the best dose and understand the side effects of selinexor when used with other drugs to treat multiple myeloma that has come back and is not responding to other treatments. Selinexor works by blocking a protein that helps cancer cells grow. Carfilzomib, pomalidomide, and dexamethasone are other drugs that may help stop cancer growth in different ways. The study aims to see if adding selinexor can better control the disease.

Description

This study is divided into two parts: Arm A and Arm B.

Arm A:

  • This part of the study is for patients who have had at least three previous treatments for multiple myeloma. It tests different doses of selinexor combined with carfilzomib, pomalidomide, and dexamethasone to find the safest and most effective dose.
  • Patients will take selinexor and dexamethasone by mouth on specific days, receive carfilzomib through an IV, and take pomalidomide by mouth over a 28-day cycle, repeated up to 18 times if the treatment is working and side effects are manageable.
  • Patients will have imaging tests and may have blood samples taken during the study.

Arm B:

  • This part is for patients who have had one or two previous treatments. It uses a fixed dose of selinexor with pomalidomide and dexamethasone.
  • Patients will take selinexor and dexamethasone by mouth on specific days and pomalidomide by mouth over a 28-day cycle, repeated up to 18 times if the treatment is working and side effects are manageable.
  • Patients will have imaging tests and may have blood samples taken during the study.

After finishing the treatment, patients will have follow-up visits to monitor their health and the progression of the disease.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with relapsed refractory multiple myeloma that is progressing.
  • Have measurable disease based on specific medical criteria.
  • For Arm A: Must have had at least three previous treatments, including specific types of drugs.
  • For Arm B: Must have had one or two previous treatments, including specific types of drugs.
  • Must agree to provide informed consent and follow study procedures.
  • Must be willing to provide tissue and blood samples for research.
  • Must have adequate organ function and blood cell counts.
  • Women of childbearing potential must agree to use effective birth control during the study and for a period after.
  • Men must agree to use effective birth control during the study and for a period after.

Exclusion Criteria

  • Recent heart attack or severe heart problems.
  • Uncontrolled infections or other serious illnesses.
  • Known HIV or active hepatitis infections.
  • Recent participation in another clinical trial or treatment with investigational drugs.
  • Recent major surgery.
  • Other active cancers within the last five years, except for certain skin or cervical cancers.
  • Uncontrolled high blood pressure or diabetes.
  • Significant nerve damage or neuropathy.
  • Known allergies to study drugs.
  • Pregnant or breastfeeding women.
  • Unable or unwilling to follow birth control guidelines during the study.

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