Daratumumab Combination Therapy for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether adding daratumumab, a new treatment, to a combination of therapies helps people with multiple myeloma live longer with fewer side effects. Multiple myeloma is a type of blood cancer affecting plasma cells in the bone marrow. The trial seeks individuals recently diagnosed with active multiple myeloma requiring treatment and who have not undergone more than four cycles of prior therapy. Participants should have high-risk disease, indicating a more aggressive cancer that needs a stronger treatment approach. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
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 this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that daratumumab, a drug for multiple myeloma, is usually well-tolerated by patients. When included in a treatment plan, it can lead to significant and lasting improvements. However, awareness of possible side effects is important. For instance, upper respiratory tract infections are a common side effect when taking daratumumab alone.
In one study, about 77.5% of patients using daratumumab alone reported infections. Although this number might seem high, these infections are often manageable. Overall, daratumumab has proven effective and offers promising results for people with multiple myeloma. Discussing any concerns with a doctor is advisable to understand the possible side effects and how they can be managed.12345Why are researchers excited about this trial's treatments?
Daratumumab combination therapy for multiple myeloma is unique because it integrates an innovative approach of using daratumumab in multiple stages of treatment, including induction, consolidation, and maintenance phases. Unlike traditional treatments that focus primarily on chemotherapy or stem cell transplants, this method leverages daratumumab's ability to target CD38 on myeloma cells, enhancing the immune system's response against the cancer. By alternating daratumumab with other drugs like carfilzomib and lenalidomide, this regimen introduces a strategic layering of therapies that could potentially improve patient outcomes by reducing the likelihood of resistance and relapse. Researchers are excited about this approach as it combines the strengths of existing treatments with novel immunological strategies, potentially offering more effective management of multiple myeloma.
What evidence suggests that daratumumab combination therapy could be effective for multiple myeloma?
Research has shown that daratumumab effectively treats multiple myeloma, a type of blood cancer. In this trial, participants will receive a combination therapy that includes daratumumab. Studies have found that a treatment plan with daratumumab can help 95% of patients eligible for a stem cell transplant avoid cancer progression for four years. In another study, daratumumab achieved a 91.7% overall response rate by the end of a specific treatment phase. For newly diagnosed patients eligible for transplants, combining daratumumab with other treatments resulted in a 100% response rate. These findings suggest that adding daratumumab to a treatment plan may help patients live longer with fewer side effects.12678
Who Is on the Research Team?
Frits van Rhee
Principal Investigator
University of Arkansas for Medical Science-Myeloma Institute
Are You a Good Fit for This Trial?
Adults aged 18-75 with newly diagnosed active Multiple Myeloma requiring treatment, who haven't had more than four cycles of MM therapy. Must have high-risk disease indicators like a specific risk score or primary plasma cell leukemia, adequate organ function, and agree to use contraception if of childbearing potential.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Participants receive induction chemotherapy with Carfilzomib, Thalidomide, Dexamethasone, Daratumumab, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide
Autologous Stem Cell Transplant (ASCT) 1
Participants undergo the first autologous stem cell transplant with Melphalan and Dexamethasone
Immunological Consolidation 1
Participants receive immunological consolidation with Daratumumab
Consolidation 1
Participants receive consolidation therapy with Daratumumab, Carfilzomib, and Dexamethasone
ASCT 2 (optional)
Participants may undergo a second autologous stem cell transplant with Melphalan and Dexamethasone
Immunological Consolidation 2
Participants receive a second round of immunological consolidation with Daratumumab
Maintenance
Participants receive maintenance therapy alternating between Dara-KD and Dara-RD in 3-month blocks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
Trial Overview
The trial is testing the addition of daratumumab to the Total Therapy approach for multiple myeloma. It aims to see if this new combination helps patients live longer with fewer side effects compared to current treatments.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Induction Chemotherapy: Carfilzomib, Thalidomide, Dexamethasone, Daratumumab , CisPlatin, Adriamycin, Cyclophosphamide and Etoposide (KTD-Dara-PACE). Autologous Stem Cell Transplant (ASCT) 1: Melphalan, Dexamethasone, ASCT. Immunological Consolidation 1: Daratumumab. Consolidation 1: Daratumumab, Carfilzomib, Dexamethasone (Dara-KD). ASCT 2 (optional): Melphalan, Dexamethasone, ASCT. Immunological Consolidation 2: Daratumumab. Maintenance: Dara-KD alternating with Daratumumab, lenalidomide, and Dexamethasone (Dara-RD) in 3-month blocks. Bortezomib may be substituted for carfilzomib throughout the regimen at the discretion of the treating physician.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Arkansas
Lead Sponsor
Janssen, LP
Industry Sponsor
Joaquin Duato
Janssen, LP
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen, LP
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Citations
DARZALEX FASPRO® (daratumumab and hyaluronidase ...
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant- ...
Clinical Results
A study confirmed that DARZALEX FASPRO ® gave patients results comparable to the IV formulation of DARZALEX ® in treating multiple myeloma when used by itself.
Real-world data on the use of subcutaneous daratumumab ...
As of the data cutoff (August 8, 2023), 49 patients were included. By the end of consolidation, 91.7% of patients achieved an overall response ( ...
Daratumumab Plus Standard Therapy for Multiple Myeloma
Slightly more patients in the daratumumab group than the standard treatment group were able to receive a stem cell transplant (90% versus 87%).
TECVAYLI® plus DARZALEX FASPRO® combination ...
In transplant-eligible patients with newly diagnosed multiple myeloma, a 100 percent overall response rate was achieved when given as the first ...
6.
jnjmedicalconnect.com
jnjmedicalconnect.com/products/darzalex/medical-content/darzalex-darzalex-faspro-adverse-event-infections-in-patients-with-newly-diagnosed-multiple-myeloDARZALEX + DARZALEX FASPRO - Adverse Event
Results - Safety - Infection-Related Events in Part 2 · Infections occurred in 77.5% (n=341) of patients in the DARZALEX monotherapy arm vs 64% ( ...
Frontline DVRd
In multiple myeloma, the most common adverse reaction (≥20%) with DARZALEX FASPRO® monotherapy is upper respiratory tract infection. The most common adverse ...
DARZALEX FASPRO® (daratumumab and hyaluronidase ...
Overall survival was also extended with DARZALEX FASPRO®, with 5-year survival rates of 93 percent versus 86.9 percent for active monitoring (HR ...
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