Daratumumab-Based Therapy for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of medications to evaluate their effectiveness for older adults with multiple myeloma, a type of blood cancer. The study focuses on treatments that include daratumumab, a drug known to target cancer cells, along with supportive medications like dexamethasone, bortezomib (also known as Velcade), and lenalidomide. Participants will receive different combinations of these drugs to identify the most effective approach. Individuals with active multiple myeloma who experience symptoms such as high calcium levels or bone issues and have not yet undergone chemotherapy might be suitable for this trial. As a Phase 2 trial, this research measures 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, you cannot use other anti-cancer treatments during the study, except for hormonal therapy, which is allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that treatments using daratumumab are generally well-tolerated by people with multiple myeloma. The FDA has approved the combination of daratumumab with bortezomib and dexamethasone for treating this condition, indicating a review of its safety by health authorities.
Other studies have found that adding lenalidomide to daratumumab and dexamethasone is also effective and generally well-tolerated. Reported side effects are similar to those expected from multiple myeloma treatments, such as mild to moderate tiredness or nausea.
Since this study is in phase 2, earlier research has already assessed the treatment's safety. This suggests it is likely safe enough for testing in more people. However, like any treatment, some risks may still exist, so discussing any concerns with a doctor is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the daratumumab-based therapy for multiple myeloma because it offers a fresh approach to tackling this cancer. Unlike standard treatments, which often involve chemotherapy or stem cell transplants, daratumumab specifically targets CD38, a protein found on the surface of myeloma cells. This targeted action can potentially improve treatment effectiveness while minimizing side effects. Additionally, the therapy's use of subcutaneous injections makes it more convenient compared to traditional intravenous methods. The combination of daratumumab with other drugs like bortezomib or lenalidomide could further enhance its cancer-fighting power, offering hope for better patient outcomes.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown that treatments using daratumumab are promising for multiple myeloma, especially when combined with other drugs. In this trial, one group of participants will receive daratumumab with dexamethasone and lenalidomide, a combination that has greatly improved the time patients live without their cancer worsening, with about 91% of patients responding well. Another group will explore adding bortezomib to daratumumab and dexamethasone, which has significantly improved survival rates. These combinations help people with multiple myeloma live longer without their cancer worsening. Overall, using daratumumab with these other drugs shows strong results in extending life and delaying disease progression.56789
Who Is on the Research Team?
Rachid C Baz, MD
Principal Investigator
H. Lee Moffitt Cancer & Research Institute
Are You a Good Fit for This Trial?
This trial is for older adults (65+) with newly diagnosed multiple myeloma who haven't had chemotherapy but may have had palliative radiotherapy or a small dose of dexamethasone. They must be able to follow the study schedule, use contraception if necessary, and have adequate organ function and bone marrow capacity. People with severe other illnesses, active infections requiring IV antibiotics, certain viral infections (HIV, hepatitis B/C), or uncontrolled medical conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daratumumab and dexamethasone for 2 months. Based on response, lenalidomide or bortezomib may be added.
Response Evaluation
Participants are evaluated for response to determine continuation or modification of treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are monitored for overall survival and progression-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Bortezomib
- Daratumumab
- Dexamethasone
- Lenalidomide
Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
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