Study on Selinexor for Treating Intermediate and High-Risk Smoldering Multiple Myeloma

Sponsor: University of Rochester

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05597345

Provider View

This clinical trial is exploring whether the drug Selinexor can help delay the progression of smoldering multiple myeloma, a condition that can develop into multiple myeloma, in patients who are at intermediate or high risk.

Patient Parameters

Program Overview

Selinexor is a medication already approved for treating multiple myeloma, a type of blood cancer. This study is investigating if low-dose Selinexor can help delay the progression of smoldering multiple myeloma (SMM) in patients who are at intermediate or high risk of developing full-blown multiple myeloma. Smoldering multiple myeloma is a condition where patients have abnormal plasma cells in their bone marrow but do not yet have symptoms. The study aims to see if Selinexor can slow down or prevent the disease from progressing to symptomatic multiple myeloma.

Description

Multiple myeloma is a cancer that affects plasma cells in the bone marrow. Before developing into multiple myeloma, many patients go through a stage called smoldering multiple myeloma (SMM), which is usually symptom-free. However, some patients with SMM are at higher risk of progressing to multiple myeloma, which can cause symptoms like high calcium levels, anemia, kidney problems, and bone damage.

This study focuses on patients with intermediate to high-risk SMM, who have a greater chance of developing multiple myeloma. Researchers are testing Selinexor, a drug that works by blocking a protein involved in cancer cell growth, to see if it can delay or prevent the progression of SMM to multiple myeloma. Selinexor has been effective in treating multiple myeloma and is now being tested in patients with SMM to see if it can offer similar benefits at a lower dose, potentially reducing side effects.

The study will monitor patients to assess the safety and effectiveness of Selinexor in delaying disease progression. Participants will receive regular check-ups and tests to track their health and the impact of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with smoldering multiple myeloma (SMM) with specific blood and bone marrow test results.
  • Should not have symptoms like high calcium levels, anemia, bone damage, or kidney problems related to the condition.
  • Must have certain risk factors indicating intermediate or high risk of progression to multiple myeloma.
  • Must have normal liver and kidney function based on recent tests.
  • Must have adequate blood cell counts and overall good health.
  • Life expectancy of more than 12 months.
  • Must be able to perform daily activities with minimal restrictions.
  • Must agree to use effective birth control methods during the study and for six months after.
  • Must understand and agree to participate in the study.

Exclusion Criteria

  • Have symptoms of multiple myeloma, such as high calcium levels, kidney problems, anemia, or bone damage.
  • Have a history of certain other medical conditions, like systemic light chain amyloidosis or recent active cancer.
  • Taking high doses of steroids for other health issues.
  • Have an active infection or untreated HIV.
  • Have digestive issues that prevent taking oral medication.
  • Pregnant, breastfeeding, or planning to become pregnant soon.
  • Not willing to use effective birth control during and after the study.
  • Have any major health or mental health issues that could interfere with the study.
  • Have previously taken Selinexor or similar drugs.

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