Study on Selinexor and Combination Treatments for Multiple Myeloma Patients

Sponsor: Karyopharm Therapeutics Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02343042

Provider View

This clinical trial is exploring the safety and effectiveness of 11 different treatment combinations involving the drug Selinexor for patients with multiple myeloma, a type of blood cancer. The study includes patients whose cancer has returned or not responded to previous treatments, as well as those newly diagnosed.

Patient Parameters

Program Overview

The study aims to evaluate how well different combinations of the drug Selinexor work in treating multiple myeloma, a cancer of the blood. It involves 11 different treatment combinations, each tested in separate groups of patients. The study will look at how safe these treatments are and how well they work in shrinking the cancer. Some patients will also participate in a special phase to understand how Selinexor is processed in the body when taken with other medications.

Description

This clinical trial is being conducted at multiple centers and is open-label, meaning both the researchers and participants know which treatments are being given. The study is divided into two phases: Dose Escalation (Phase 1) and Expansion (Phase 2). In Phase 1, the goal is to find the safest dose of Selinexor when combined with other drugs. In Phase 2, the focus is on how effective these combinations are in treating multiple myeloma.

Patients will be assigned to different treatment groups based on their medical history and the specifics of their cancer. Some patients will undergo a preliminary phase to study how Selinexor interacts with other drugs in the body. This involves taking Selinexor alone and then with another medication to see how it affects the drug's behavior in the body.

The study includes various combinations of Selinexor with other drugs like dexamethasone, pomalidomide, bortezomib, and others. Each combination is tested in a specific group of patients to determine the best treatment approach for different types of multiple myeloma.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of multiple myeloma with measurable disease.
  • Have symptoms of multiple myeloma as per medical guidelines.
  • Must have measurable levels of specific proteins in the blood or urine.
  • Must have resolved any side effects from previous treatments to a mild level.
  • Must have a performance status indicating they are able to carry out daily activities with some limitations.
  • Must have adequate liver and kidney function as shown by specific blood tests.
  • Must have adequate blood cell counts.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.
  • Must have received certain previous treatments for multiple myeloma, depending on the specific treatment group they are assigned to.

Exclusion Criteria

  • Have a type of multiple myeloma that does not produce measurable proteins.
  • Have active amyloidosis or plasma cell leukemia.
  • Have received certain blood transfusions or growth factors recently.
  • Have had recent radiation, chemotherapy, or other cancer treatments.
  • Have a history of severe heart problems or uncontrolled high blood pressure.
  • Have active infections or certain viral infections like hepatitis or HIV.
  • Have gastrointestinal issues that prevent swallowing pills.
  • Are pregnant or breastfeeding.
  • Have a serious psychiatric or medical condition that could interfere with the study.
  • Have allergies to any of the study drugs.
  • Have a history of certain types of neuropathy or are taking medications that interfere with the study drugs.

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