Daratumumab-based Therapy for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment approach for people with multiple myeloma, a type of blood cancer. The study tests a combination of medications, including daratumumab (an immunotherapy drug), to determine if they can help more patients achieve minimal residual disease (MRD)-negative status, meaning no detectable signs of cancer. The trial includes an initial phase of treatment and, if needed, additional treatment to consolidate the results. This trial suits individuals diagnosed with active multiple myeloma who can handle the treatment regimen and have not yet undergone more than one round of anti-myeloma therapy. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using strong CYP3A4 inducers, you may need to switch to an alternative medication while receiving Bortezomib.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that treatments using daratumumab have been tested in people with multiple myeloma and have demonstrated promising safety results. When combined with other drugs like lenalidomide and dexamethasone, daratumumab is usually well-tolerated. In past studies, most patients managed side effects such as tiredness and nausea without major issues.
Lenalidomide and dexamethasone are also commonly used in treating multiple myeloma and have well-known safety records. Typical side effects include low blood counts and a higher risk of infections, but these can usually be managed with medical help.
The FDA has approved daratumumab for treating multiple myeloma, supporting its safety. While all treatments can have side effects, evidence so far suggests these therapies are generally safe for most patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the Daratumumab-based therapy for multiple myeloma because it offers a unique approach compared to existing treatments. Most treatments for multiple myeloma, like bortezomib or lenalidomide alone, focus on suppressing the cancer cells' growth. However, Daratumumab is an antibody that specifically targets CD38, a protein found on the surface of multiple myeloma cells, marking them for destruction by the immune system. This targeted mechanism is combined with a phased regimen that adapts based on the patient's response, potentially enhancing the treatment's effectiveness and personalizing the approach to each patient's needs.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that the combination of daratumumab, lenalidomide, and dexamethasone (Dara-Rd), administered during the induction phase of this trial, effectively treats multiple myeloma, a type of blood cancer. Studies have found that this combination can reduce cancer cells to very low levels, achieving minimal residual disease (MRD) negativity. Participants with MRD positivity after induction will receive an additional drug, bortezomib, during the consolidation phase (Dara-RVd), which has further reduced cancer cells in past studies. The FDA has approved this combination for patients with newly diagnosed multiple myeloma who are eligible for stem cell transplants. Patients using these treatments have experienced longer periods without cancer progression. Overall, evidence supports the effectiveness of these combinations in managing multiple myeloma.45678
Who Is on the Research Team?
Jing Ye, M.D.
Principal Investigator
MD Anderson
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed Multiple Myeloma who have measurable disease and can tolerate treatments, including high-dose chemotherapy and stem cell transplant if needed. Participants must not have had more than one cycle of myeloma therapy before joining, be free from certain blood/liver diseases, HIV, Hepatitis B/C, other active cancers in the last five years, or significant heart or lung conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Participants receive induction therapy with Daratumumab, Lenalidomide, and Dexamethasone (Dara-Rd)
Consolidation Therapy
Participants with MRD-positive status receive consolidation therapy with Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone (Dara-RVd)
Maintenance Therapy
Participants receive maintenance therapy with Daratumumab and Lenalidomide (Dara-R), followed by Lenalidomide alone until progression or intolerance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bortezomib
- Daratumumab
- Dexamethasone
- Lenalidomide
Daratumumab is already approved in European Union, United States for the following indications:
- Relapsed and refractory multiple myeloma
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Multiple myeloma in patients who have received at least three prior therapies
- Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
- Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor
Janssen Scientific Affairs, LLC
Industry Sponsor
Joaquin Duato
Janssen Scientific Affairs, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Scientific Affairs, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University