Phase 2 Study of Selinexor and Bispecific Antibody for Treating Relapsed/Refractory Multiple Myeloma

Sponsor: Duke University

Sponsor score: 0

ClinicalTrials ID:NCT06822972

This clinical trial is testing the safety and effectiveness of combining the drug Selinexor with a bispecific antibody therapy in patients with multiple myeloma that has returned or not responded to previous treatments. The study will monitor how well the treatment works over 12 months and follow patients for an additional 24 months.

Patient Parameters

Program Overview

The main goal of this study is to see if the combination of Selinexor and a bispecific antibody therapy is safe for patients with relapsed or refractory multiple myeloma, and to check how many patients have no detectable cancer cells in their bone marrow after 12 months of treatment. The study will include 27 patients who are already receiving bispecific antibody therapy. Participants will be treated for 12 months or until their disease progresses, and they will be monitored for a total of 24 months. During the study, patients will keep a drug diary, have regular safety check-ins, and undergo various medical assessments and lab tests.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to provide written consent to participate.
  • Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Diagnosed with symptomatic multiple myeloma that has returned or not responded to at least four previous treatments, including specific types of drugs.
  • Eligible to receive certain bispecific antibody therapies as per approved guidelines.
  • Any previous side effects from bispecific antibody therapy must be resolved before starting Selinexor.
  • Have measurable disease based on specific medical tests.
  • Have adequate liver and kidney function as shown by recent lab tests.
  • Have adequate blood cell counts.
  • Women who can become pregnant must have a negative pregnancy test before starting treatment.
  • All participants must agree to use effective birth control during the study and for five months after the last dose.
  • Women must agree not to donate eggs, and men must agree not to donate sperm during the study and for 90 days after the last dose.

Exclusion Criteria

  • Previously treated with Selinexor or similar drugs and did not respond.
  • Have any uncontrolled medical conditions that could interfere with the study.
  • Have an active infection requiring treatment within one week before starting the study.
  • Pregnant or breastfeeding women.
  • Have unstable heart conditions or recent heart attack.
  • Have certain viral infections unless they are well-controlled.
  • Have unresolved side effects from previous bispecific antibody treatment.
  • Have digestive issues that prevent swallowing or absorbing the medication.
  • Unable or unwilling to take supportive medications for side effects.
  • Have any condition that could interfere with the study or giving consent.
  • Have allergies to any required medications or treatments.
  • Unwilling or unable to follow the study protocol.

Locations

FACILITYZIPCITYSTATE
Duke University Health System27705DurhamNorth Carolina

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