Bendamustine + Pomalidomide + Dexamethasone for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a combination of three drugs—Bendamustine, Pomalidomide, and Dexamethasone—to find an effective treatment for multiple myeloma, a type of blood cancer. The goal is to determine the best dosage and assess how well this combination works for patients whose cancer has returned or did not respond to previous treatments. Different groups receive slightly varied doses to find the optimal balance. This trial may suit those diagnosed with multiple myeloma who have not had success with lenalidomide and are experiencing a relapse or progression of the disease. As a Phase 1/Phase 2 trial, it focuses on understanding how the treatment works in people and measuring its effectiveness in an initial group, offering a chance to contribute to groundbreaking research.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have used experimental drugs, chemotherapy, or steroids within 14-21 days before starting the trial. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of bendamustine, pomalidomide, and dexamethasone has been tested for safety in people with multiple myeloma, a type of blood cancer. Studies have found that this combination is generally well-tolerated.
Bendamustine is already used for multiple myeloma that has returned or hasn't responded to other treatments. Patients in studies have generally managed this treatment well, though, like many cancer treatments, it can have side effects. These may include low blood counts, which can increase the risk of infection, as well as tiredness and nausea.
Pomalidomide and dexamethasone are often used together to treat multiple myeloma and are also considered generally safe. However, they can cause side effects like low blood cell counts and a higher risk of blood clots.
Overall, evidence suggests this treatment combination has been safe for many patients, but side effects can differ from person to person. Regular check-ups and discussions with healthcare providers are important while on treatment.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for multiple myeloma because they combine bendamustine, pomalidomide, and dexamethasone in a new way that could enhance effectiveness against the cancer cells. Unlike traditional treatments, which often rely on separate mechanisms, this combination potentially offers a synergistic effect, targeting the cancer in multiple ways. Pomalidomide, which modulates the immune system, is given with bendamustine, a chemotherapy drug, and dexamethasone, a steroid, potentially enhancing the overall treatment response while maintaining a convenient dosing schedule. This approach could improve outcomes for patients who have not responded well to existing therapies.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Studies have shown that the combination of Bendamustine, Pomalidomide, and Dexamethasone (BPD) holds promise for treating relapsed or refractory multiple myeloma, a type of blood cancer. This trial will evaluate different dosages of Pomalidomide within the BPD combination. Research indicates that patients treated with BPD often live longer, making it a strong option for those whose previous treatments have failed. The combination is practical and effective even for patients who have undergone many treatments, suggesting they may still benefit from it.14567
Who Is on the Research Team?
Gwynn Long, MD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with relapsed or refractory multiple myeloma, who have seen their cancer progress after treatment, including lenalidomide. They should have a life expectancy of more than 3 months and be able to perform daily activities with minimal assistance (ECOG Performance Status of 0-2). Their liver function must also meet certain criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Patients are enrolled in cohorts to determine the maximum tolerated dose (MTD) using a 3+3 design
Treatment
Participants receive Bendamustine, Pomalidomide, and Dexamethasone in 28-day cycles for up to 12 cycles
Maintenance
Participants continue with Pomalidomide and Dexamethasone until disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bendamustine
- Dexamethasone
- Pomalidomide
Bendamustine is already approved in United States, European Union, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
- Multiple myeloma
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
- Chronic lymphocytic leukemia
- Non-Hodgkin lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cristina Gasparetto
Lead Sponsor
Celgene
Industry Sponsor
Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania