Selinexor + Antibody for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of combining Selinexor, a cancer drug, with a commercial bispecific antibody therapy for patients with relapsed or refractory multiple myeloma. Researchers aim to determine if this combination can help more patients achieve a state where no minimal residual disease is detected after 12 months of treatment. Patients who have tried at least four different treatments, including proteasome inhibitors and immunomodulatory agents, and have symptomatic multiple myeloma might be suitable for this trial. Participants will engage in the study for up to two years, with frequent check-ins and lab tests. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to advancements in multiple myeloma care.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using Selinexor with a bispecific antibody is generally safe for patients with relapsed or refractory multiple myeloma, a type of blood cancer. Studies have found that bispecific antibodies work well for patients who have already tried several treatments and usually have manageable side effects.
When Selinexor is administered at a lower dose once a week alongside other myeloma treatments, patients experience fewer or less severe side effects. Real-world studies have examined the safety of Selinexor combinations, and the results are promising, with side effects similar to those observed in controlled studies.
Overall, while some side effects can occur, the treatment is generally well-tolerated. This suggests that both Selinexor and the bispecific antibody are safe options for further study in clinical trials.12345Why do researchers think this study treatment might be promising for multiple myeloma?
Unlike the standard treatments for multiple myeloma, which usually involve chemotherapy or proteasome inhibitors, Selinexor combined with a bispecific antibody offers a novel approach. Selinexor works by blocking the export of tumor suppressor proteins from the nucleus, which can lead to cancer cell death, while the bispecific antibody is designed to engage and activate T-cells to attack myeloma cells. This dual mechanism not only targets the cancer cells directly but also enhances the immune system's response against the tumor, potentially leading to more effective treatment outcomes. Researchers are excited about this combination because it represents a promising strategy to overcome resistance seen with existing therapies.
What evidence suggests that Selinexor + bispecific antibody could be effective for Multiple Myeloma?
Research has shown that combining selinexor with other treatments for multiple myeloma is promising. In earlier studies, 78.1% of patients who took selinexor with other anti-multiple myeloma drugs responded well to the treatment. Some of these patients even achieved a complete response, with no detectable cancer. Real-world studies have indicated that patients using selinexor combinations lived for about 14.7 months on average. In this trial, participants will receive a combination of selinexor with a bispecific antibody. This combination aims to improve results further, with the hope of increasing the number of patients who have no detectable cancer cells, even at very sensitive levels.14678
Who Is on the Research Team?
Yubin Kang, MD
Principal Investigator
Duke Health
Are You a Good Fit for This Trial?
This trial is for adults with Multiple Myeloma that's come back or hasn't responded to treatment. They must have tried at least four previous treatments including specific inhibitors and antibodies, be in a stable condition (ECOG ≤2), and agree to receive teclistamab, elranatamab, or talquetamab. Patients should not join if they've had severe reactions from bispecific antibody therapy without full recovery.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Selinexor in combination with bispecific antibody therapy for 12 months or until disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Selinexor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor