Linvoseltamab for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies a new treatment, linvoseltamab, for individuals with multiple myeloma, a type of blood cancer that has returned or stopped responding to other treatments. Linvoseltamab helps the immune system target and kill cancer cells by connecting to specific proteins on these cells and immune cells. The trial seeks to determine the best dosing schedule to maintain effectiveness while reducing side effects. It suits those with multiple myeloma that hasn't responded to at least three different types of therapy and who can tolerate frequent clinic visits. As a Phase 1, Phase 2 trial, this research focuses on understanding how linvoseltamab works in people and measuring its effectiveness in an initial, smaller group, offering participants the chance to contribute to groundbreaking cancer treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking 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 linvoseltamab is likely to be safe for humans?
Research has shown that linvoseltamab, a treatment for relapsed or hard-to-treat multiple myeloma, is generally safe. Studies have found that patients using linvoseltamab experienced strong and lasting improvements, indicating the treatment's effectiveness over a significant period. These studies also report that the treatment is usually well-tolerated, with manageable side effects.
Linvoseltamab has been tested in patients whose multiple myeloma did not improve with previous treatments. The results were encouraging, with a 100% response rate in some high-risk patients, meaning every patient in that group benefited from the treatment. Importantly, the safety of linvoseltamab remained consistent across different studies, suggesting it is reliably safe for those considering joining a trial.12345Why do researchers think this study treatment might be promising for multiple myeloma?
Linvoseltamab is unique because it targets a protein called BCMA on the surface of multiple myeloma cells, which is different from standard treatments like chemotherapy and immunomodulatory drugs. This targeted approach allows linvoseltamab to directly attack cancer cells while sparing more healthy cells, potentially leading to fewer side effects. Additionally, linvoseltamab offers flexible dosing schedules, ranging from weekly to every 12 weeks, which could make treatment more convenient for patients compared to the more frequent dosing required by some current therapies. Researchers are excited about linvoseltamab because it represents a novel way to tackle multiple myeloma and could offer new hope for patients who haven't responded to other treatments.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that linvoseltamab is effective for people with relapsed or hard-to-treat multiple myeloma. One study found that 71% of patients responded to the treatment, with half achieving a complete response, meaning no signs of cancer were detected. Linvoseltamab targets specific proteins on cancer and immune cells, aiding the immune system in attacking the cancer. This trial will evaluate different dosing schedules of linvoseltamab, including step-up dosing and various cohort schedules, to assess its effectiveness and safety. This treatment is considered a highly effective option for those who have tried other therapies without success. Evidence suggests that linvoseltamab could be a promising choice for managing multiple myeloma when other treatments have not worked.15678
Who Is on the Research Team?
Madhav Dhodapkar, MBBS
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for patients with multiple myeloma that has relapsed, is refractory, or resistant to three classes of treatments. Participants should have measurable disease and be eligible for bone marrow procedures. Specific criteria about prior therapies and health status apply.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Step-up Dosing
Patients receive linvoseltamab IV over 30-240 minutes once a week for 14 weeks, then every 2 weeks thereafter, with evaluations for disease response starting at week 3 and continuing every 4 weeks.
Dose De-escalation
Patients achieving VGPR or better after 14 weeks are assigned to one of three dose de-escalation cohorts, receiving linvoseltamab every 4, 8, or 12 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- Linvoseltamab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Center
Lead Sponsor
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School