Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma

Sponsor: US Oncology Research

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04782687

Provider View

This clinical trial is testing a new combination of drugs, including selinexor, daratumumab, lenalidomide, and dexamethasone, to see if they can effectively treat newly diagnosed multiple myeloma as a first-line treatment.

Patient Parameters

Program Overview

This study is exploring the effects of a new drug combination for treating multiple myeloma, a type of blood cancer. The combination includes selinexor, which is already approved for use in certain cases of multiple myeloma, along with daratumumab, lenalidomide, and dexamethasone. The goal is to see if using all four drugs together can improve treatment outcomes for patients who are newly diagnosed with this disease.

Description

Multiple myeloma is a serious blood cancer that is difficult to cure and often becomes resistant to treatment. This study aims to find better ways to treat it from the start. The new treatment being tested combines four drugs: selinexor, daratumumab, lenalidomide, and dexamethasone. Each of these drugs has shown promise in treating multiple myeloma, and the study will see if using them together can help patients live longer and keep the cancer from coming back.

Selinexor has been effective in earlier studies and is already approved for use in patients who have tried other treatments without success. Daratumumab, lenalidomide, and dexamethasone are also approved for treating multiple myeloma and have been shown to work well together. This study will test if adding selinexor to this combination can improve results for patients who are just starting treatment.

The study will monitor how well patients respond to the treatment, how long they remain free of cancer progression, and any side effects they experience. The hope is that this new combination will lead to deeper and longer-lasting remissions for patients with newly diagnosed multiple myeloma.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Have a confirmed diagnosis of multiple myeloma based on specific medical criteria.
  • Have measurable disease, meaning the cancer can be tracked using standard tests.
  • Have not received any previous treatment for multiple myeloma, except for a short course of steroids or radiation if needed.
  • Be in good overall health with a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after the last dose.
  • Men must agree to use effective contraception during the study and for 3 months after the last dose and not donate sperm during this time.
  • Be willing and able to follow the study requirements and sign an informed consent form.

Exclusion Criteria

  • Have a history of or current central nervous system involvement by multiple myeloma.
  • Test positive for HIV, hepatitis B, or have a history of hepatitis C, unless treated and clear of the virus for at least 6 months.
  • Have any medical condition that could interfere with the study or pose a risk to the patient.
  • Have significant heart disease or uncontrolled heart conditions.
  • Have abnormal lab test results that do not meet the study's requirements.
  • Have known allergies to any of the study drugs or their components.
  • Have other specific types of blood disorders or conditions.
  • Be unable to comply with the study protocol due to other health issues or personal circumstances.
  • Be planning to become pregnant or have major surgery during the study period.
  • Be eligible for a stem cell transplant and planning to undergo one within 24 months of starting the study.

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