Continued Elotuzumab Treatment for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assist individuals with multiple myeloma (a type of blood cancer) who have already benefited from an existing treatment called elotuzumab (also known as Empliciti). The study will continue to provide elotuzumab, possibly with other medications, to those who participated in previous trials of this treatment and cannot access it elsewhere. Suitable candidates for this trial include those who have participated in a past elotuzumab trial and are currently benefiting from it. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It seems focused on continuing elotuzumab treatment for those already benefiting from it.
Is there any evidence suggesting that elotuzumab is likely to be safe for humans?
Research has shown that elotuzumab has been tested in people with multiple myeloma, a type of blood cancer. In a previous study, adding elotuzumab to standard treatments slowed the disease's progression. However, some side effects occurred. For instance, about 9% of patients developed new types of cancer, compared to 6% of those who didn't take elotuzumab.
People with other health issues, especially heart problems, might experience more side effects. Among those already taking elotuzumab, 41.1% showed signs of improvement. These findings suggest that while there are some risks, elotuzumab can benefit many patients. Prospective trial participants should discuss health concerns with a doctor.12345Why are researchers excited about this trial's treatments?
Elotuzumab is unique because it specifically targets a protein called SLAMF7 on the surface of myeloma cells. Unlike traditional treatments for multiple myeloma, such as chemotherapy or proteasome inhibitors, elotuzumab works by enhancing the body's immune response to attack and destroy these cancerous cells. Researchers are excited about this treatment because it offers a more targeted approach, potentially leading to better outcomes with fewer side effects. This innovative mechanism of action sets it apart from conventional therapies, providing hope for patients who continue to benefit from previous elotuzumab protocols.
What is the effectiveness track record for elotuzumab in treating multiple myeloma?
Research has shown that elotuzumab effectively treats multiple myeloma, a type of blood cancer. When combined with other drugs, elotuzumab can significantly improve patient outcomes. Specifically, patients receiving elotuzumab-based treatments lived for a median of up to 5.64 years. Additionally, combining elotuzumab with other therapies reduced the risk of disease progression or death by 29%. The overall response rate, indicating how well patients respond to treatment, reached 55% in some studies. These findings suggest that elotuzumab can be a valuable option for patients whose multiple myeloma has returned or is not responding to other treatments. In this trial, all participants will continue to receive elotuzumab and/or other study drugs according to their previous protocol.46789
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for adults who have benefited from previous elotuzumab studies for multiple myeloma and are currently on treatment. It's not open to those who stopped earlier trials for any reason or aren't seeing benefits from the past treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants continue to receive elotuzumab and/or other study drugs as per previous protocol
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Elotuzumab
Trial Overview
The study continues providing elotuzumab and possibly other drugs like Dexamethasone, Bortezomib, Pomalidomide, Nivolumab, or Lenalidomide to participants of prior related trials where commercial supply isn't available.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This is a continuation roll-over study for patients receiving benefit from prior elotuzumab protocols. All participants will receive elotuzumab and/or other study drugs as per previous protocol.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
AbbVie
Industry 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
Citations
Real world outcomes with elotuzumab-based therapies for ...
The median OS for patients treated with EPd was 2.55 years and was 5.64 years for patients treated with ERd. For Dara-refractory patients, the ...
Empliciti (Elotuzumab): First SLAMF7 Antibody Therapy ...
New longer-term data for Empliciti (elotuzumab) showed a continued progression-free survival benefit in patients with relapsed or refractory multiple myeloma.
Four-Year Follow-up with Empliciti (elotuzumab) Plus ...
Combination therapy demonstrated a sustained reduction in risk of progression/death of 29% and relative improvement of 50% in ...
Elotuzumab Therapy for Relapsed or Refractory Multiple ...
Multiple myeloma, a malignant disease of monoclonal plasma cells, has a median overall survival of approximately 5 years. Despite improvements ...
The Real-World Outcomes of Relapsed/Refractory Multiple ...
The overall response rate was 55%. With a median follow-up of 20.2 months, the median progression-free survival (PFS) was 9.1 months (95% ...
Empliciti (Elotuzumab)
The ELOQUENT-2 clinical trial demonstrated that the addition of Empliciti to Rd resulted in a 27% reduction in the risk of disease progression ...
Safety and Effectiveness of Elotuzumab in Japanese ...
The presence of comorbidities, particularly cardiovascular disorders, significantly affected the safety. The overall response rate was 41.1%.
EMPLICITI® (elotuzumab) | Indications and Important ...
In the EMPLICITI ELOQUENT-2 trial (N=635), invasive second primary malignancies (SPM) were 9% (ERd) and 6% (Rd). The rate of hematologic malignancies was the ...
New Longer-Term Data for Empliciti (elotuzumab) Showed ...
In a clinical trial of patients with multiple myeloma (N=635), invasive second primary malignancies (SPM) were 9.1% (ERd) and 5.7% (Rd). The ...
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