Combination Therapy for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of four drugs to treat multiple myeloma that has returned or is not responding to treatment. The aim is to evaluate how well elotuzumab (Empliciti), carfilzomib, lenalidomide, and dexamethasone work together against this type of cancer. Individuals who have experienced a relapse or have not responded to previous treatments for multiple myeloma might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial requires a 'washout' period, meaning you need to stop certain previous treatments before starting the study drugs. Prior chemotherapy must be completed more than 3 weeks before starting the trial, and other specific treatments have different required timeframes. It's best to discuss your current medications with the trial team to see how they fit with these requirements.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that elotuzumab, when combined with treatments like lenalidomide and dexamethasone, is generally well-tolerated by patients with multiple myeloma. The FDA has approved it for this purpose. However, about 80% of patients experience serious blood-related side effects. Carfilzomib also has FDA approval for multiple myeloma and is frequently used with lenalidomide and dexamethasone, indicating strong safety data for both elotuzumab and carfilzomib in treating relapsed or hard-to-treat multiple myeloma. While using all four drugs together in this trial is new, each drug has a proven safety record individually and in smaller combinations.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the combination therapy for multiple myeloma, particularly with the use of Elotuzumab, because it offers a unique approach to treatment. Unlike standard therapies, which often include drugs like bortezomib or thalidomide that target the cancer cells directly, Elotuzumab works by activating the body's immune system to attack the myeloma cells. This immunotherapy approach is promising as it potentially enhances the body's own defenses, offering a new avenue for patients who might not respond well to existing treatments. Additionally, the combination of Elotuzumab with other drugs like carfilzomib and lenalidomide could lead to improved outcomes by utilizing multiple mechanisms to combat the disease.
What evidence suggests that this trial's combination therapy could be effective for multiple myeloma?
In this trial, participants will receive a combination therapy that includes elotuzumab, lenalidomide, dexamethasone, and carfilzomib. Research has shown that elotuzumab, when combined with other medications, effectively treats relapsed or refractory multiple myeloma. Specifically, studies have found that combining elotuzumab with lenalidomide and dexamethasone prolongs the period before the cancer worsens. Real-world evidence confirms that patients on elotuzumab-based treatments have lived significantly longer, with some surviving several additional years. Additionally, carfilzomib, another drug in this study, is already approved for treating multiple myeloma and is often used with lenalidomide and dexamethasone. Together, these drugs have demonstrated a strong ability to manage the disease effectively.678910
Who Is on the Research Team?
Manisha Bhutani, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
Adults with relapsed/refractory multiple myeloma who've had only one prior treatment can join. They must be in decent health, not pregnant, willing to use contraception, and have no major illnesses or surgeries recently. People with certain types of MM, CNS involvement, uncontrolled illness, recent investigational drug use or known allergies to the drugs are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive induction therapy with carfilzomib, lenalidomide, dexamethasone, and elotuzumab for 4 cycles
Maintenance Therapy
Participants receive maintenance therapy with elotuzumab and lenalidomide until relapse or progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Elotuzumab
Trial Overview
The trial tests a combination of elotuzumab with carfilzomib, lenalidomide and dexamethasone in patients whose multiple myeloma has returned after treatment. This four-drug combo is experimental and aims to see how well it works together for this condition.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Induction (4 28-day cycles): Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4 Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4) Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4 Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4 Maintenance (28-day cycles): Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n) Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
Elotuzumab is already approved in United States, European Union, Canada for the following indications:
- Multiple myeloma
- Multiple myeloma
- Multiple myeloma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
Saad Z. Usmani, MD
Lead Sponsor
Manisha Bhutani
Lead Sponsor
Atrium Health Levine Cancer Institute
Collaborator
Bristol-Myers Squibb
Industry 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
Levine Cancer Institute
Collaborator
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 ...
The most common AEs (all grades) in ELd and Ld, respectively, were diarrhea (49%, 38%), fatigue (48%, 41%), anemia (43%, 38%), pyrexia (40%, 25 ...
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% ...
Elotuzumab Therapy for Relapsed or Refractory Multiple ...
The objective of this randomized, phase 3 trial, called ELOQUENT-2, was to evaluate the efficacy and safety of elotuzumab in combination with ...
EMPLICITI® (elotuzumab) | Indications and Important ...
Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts ...
EMPLICITI® (elotuzumab) | Official Patient Website
EMPLICITI® (elotuzumab) is used in combination with other treatments to treat multiple myeloma · Important Safety Information and Indications · WARNINGS FOR ...
Empliciti (Elotuzumab)
Empliciti® (elotuzumab) is treats multiple myeloma in combination with other drugs. Read about possible side effects, dosing schedule and ...
9.
ema.europa.eu
ema.europa.eu/en/documents/product-information/empliciti-epar-product-information_en.pdfEmpliciti, INN-elotuzumab - EMA
Summary of safety profile. The safety data of elotuzumab have been assessed from a total of 682 patients with multiple myeloma treated with elotuzumab in ...
Elotuzumab (Empliciti) - Medical Clinical Policy Bulletins
Aetna considers elotuzumab (Empliciti) medically necessary for the treatment of previously treated multiple myeloma when any of the following criteria are met.
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