Etentamig + Daratumumab for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, Etentamig, for treating multiple myeloma, a blood cancer affecting plasma cells that can cause bone pain, fractures, and kidney problems. It explores different doses of Etentamig combined with other treatments to assess effectiveness and identify any side effects. The trial consists of two phases with distinct treatment plans, and participants will attend regular hospital visits for monitoring. It seeks adults recently diagnosed with multiple myeloma who cannot undergo high-dose chemotherapy or stem cell transplants due to potential complications. As a Phase 2 and Phase 3 trial, this study measures Etentamig's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who have had prior systemic therapy for multiple myeloma or have taken investigational treatments recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has raised safety concerns about the combination of Etentamig and Daratumumab. A study reported deaths, primarily due to disease progression, but this does not fully reflect the treatment's overall safety.
In contrast, the combination of Daratumumab, Lenalidomide, and Dexamethasone (DRd) is considered safer. Studies have found that patients using this combination lived longer without disease progression compared to other treatments.
While DRd is well-established, Etentamig remains under investigation, making its safety less certain. Its presence in later testing stages suggests promise, but potential risks must be considered. Participation in trials involves careful monitoring to manage any side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for multiple myeloma because they explore innovative combinations and dosages that could enhance effectiveness. Etentamig, when combined with daratumumab, is being tested at different doses to find the most effective one, marking a shift from standard treatments like bortezomib and carfilzomib. This combination could offer a new mechanism of action by potentially increasing the immune system's ability to target and destroy myeloma cells. Moreover, since daratumumab is already a well-established therapy, adding etentamig might improve outcomes by offering a synergistic effect, leading to better patient responses.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research has shown promising results for using etentamig and daratumumab together to treat multiple myeloma (MM). Lab tests demonstrated that this combination effectively kills MM cells. In this trial, participants will receive varying doses of etentamig combined with daratumumab to determine the optimal dose. Other studies have found that when etentamig is combined with different treatments, 81% of patients experienced a reduction or disappearance of their cancer.
Another treatment arm in this trial involves the combination of daratumumab, lenalidomide, and dexamethasone (DRd), which has proven effective in helping patients live longer without their disease worsening. Specifically, one study showed that 72% of patients treated with DRd did not see their cancer progress for at least 18 months. Both treatment combinations in this trial show strong potential for helping people with MM.24678Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
Adults with a new diagnosis of multiple myeloma who aren't suitable for high-dose chemotherapy and stem cell transplants due to potential negative impacts on tolerability. They must meet specific diagnostic criteria, including certain levels of M-protein in the blood or urine, or serum free light chain measurements.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 2 Treatment
Participants receive one of three doses of etentamig in combination with daratumumab
Phase 3 Treatment
Participants receive etentamig at RP3D in combination with daratumumab, or DRd regimen
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Daratumumab
- Dexamethasone
- Etentamig
- Lenalidomide
Trial Overview
The trial is testing Etentamig combined with Daratumumab versus a known treatment combo (Daratumumab, Lenalidomide, Dexamethasone) for multiple myeloma. It's divided into two phases: Phase 2 tests three doses of Etentamig; Phase 3 compares the best dose from Phase 2 against the standard treatment.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Participants will receive etentamig at the RP3D in combination with daratumumab, as part of the approximately 16 year study duration.
Participants will receive DRd, as part of the approximately 16 year study duration.
Participants will receive etentamig dose C in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Participants will receive etentamig dose B in combination with daratumumab until the RP3D, as part of the approximately 16 year study duration.
Participants will receive etentamig dose A in combination with daratumumab until the recommended phase 3 dose (RP3D), as part of the approximately 16 year study duration.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
IFM (Intergroupe Français du Myélome); PETHEMA (Program for the Study and Treatment of Haematological Malignances)
Collaborator
IFM (Intergroupe Français du Myélome)
Collaborator
PETHEMA (Program for the Study and Treatment of Haematological Malignances)
Collaborator
Citations
Overall Survival With Daratumumab, Lenalidomide ... - PMC
Daratumumab in combination with lenalidomide and dexamethasone (D-Rd) significantly prolonged progression-free survival versus lenalidomide and dexamethasone ( ...
Daratumumab, Lenalidomide, and Dexamethasone for ...
At 18 months, the rate of progression-free survival was 72%, and the rate of overall survival was 90%. ... Here we report the results of a ...
Daratumumab/lenalidomide/dexamethasone in transplant- ...
In the MAIA study, daratumumab plus lenalidomide and dexamethasone (D-Rd) improved progression-free survival (PFS) and overall survival (OS) ...
Real-World Treatment Outcomes of Different Sequencing ...
These results suggest that the use of 1L DRd may provide the best outcomes for patients with transplant-ineligible NDMM. Keywords: daratumumab; lenalidomide; ...
5.
ashpublications.org
ashpublications.org/blood/article/124/21/84/101788/Safety-and-Efficacy-of-Daratumumab-withSafety and Efficacy of Daratumumab with Lenalidomide and ...
Available preliminary efficacy data from 20 patients demonstrated marked decrease in M-protein in all patients; 15/20 patients achieved PR or ...
Efficacy and Safety of Daratumumab, Lenalidomide ... - PMC
Patients receiving D-Rd experienced a median progression-free survival (PFS) of 45.0 months, significantly longer than the 17.5 months observed with Rd alone.
Safety and efficacy of a dexamethasone-sparing regimen ...
Patients with frailty and newly diagnosed multiple myeloma have worse outcomes due to higher rates of adverse events (AEs) and treatment discontinuation.
Overall Survival With Daratumumab, Lenalidomide, and ...
Daratumumab in combination with lenalidomide and dexamethasone (D-Rd) significantly prolonged progression-free survival versus lenalidomide and dexamethasone ( ...
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