Study on Selinexor, Daratumumab, Carfilzomib, and Dexamethasone for Treating High-Risk, Recurrent, or Resistant Multiple Myeloma

Sponsor: Academic and Community Cancer Research United

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04756401

Provider View

This clinical trial is testing a new combination of drugs, including selinexor, carfilzomib, daratumumab, and dexamethasone, to see if they can better treat multiple myeloma that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

This study is exploring whether adding the drug selinexor to a combination of carfilzomib, daratumumab, and dexamethasone can improve treatment outcomes for patients with high-risk multiple myeloma that has come back or not responded to previous treatments. Selinexor works by blocking a protein needed for cancer cell growth, while carfilzomib and daratumumab help destroy cancer cells in different ways. Dexamethasone is used to reduce inflammation and support the other drugs in fighting cancer.

Description

The main goal of this study is to see if the combination of selinexor, daratumumab, carfilzomib, and dexamethasone can reduce the amount of cancer left in the bone marrow of patients with high-risk multiple myeloma. Researchers will also look at how well patients respond to the treatment, how long the response lasts, and how long patients live without the cancer getting worse. The safety of the treatment will also be evaluated.

Patients in the study will receive carfilzomib through an IV on specific days, daratumumab through an IV on a set schedule, and take dexamethasone and selinexor by mouth on certain days. Treatment cycles repeat every 28 days as long as the cancer does not progress and side effects are manageable.

After finishing the study treatment, patients will be monitored every 3 months if their cancer has not progressed, and every 6 months if it has, for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a history of multiple myeloma that has returned or not responded to treatment.
  • Must be sensitive to selinexor and carfilzomib.
  • Can have had daratumumab before, but not within the last 6 months.
  • Have high-risk disease based on specific genetic markers or other criteria.
  • Have measurable disease and have received 1-3 prior treatments.
  • Be in good overall health with a performance status of 0 to 2.
  • Have adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Must be able to complete questionnaires and provide written consent.
  • Willing to return for follow-up visits.

Exclusion Criteria

  • Have had daratumumab treatment within the last 6 months.
  • Have disease that did not respond to carfilzomib.
  • Pregnant or nursing women, or those not willing to use contraception.
  • Have severe health conditions that could interfere with the study.
  • Have uncontrolled high blood pressure or significant heart disease.
  • Have active infections or other serious illnesses.
  • Have had recent radiation or surgery.
  • Have other active cancers, except for certain non-threatening types.
  • Have active central nervous system involvement or certain syndromes.

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