Continued Elotuzumab Treatment for Multiple Myeloma

Not currently recruiting at 92 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Must be taking: Elotuzumab

Disqualifiers: Discontinued elotuzumab, No benefit, Unwell, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

Why 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. ^{4 6 7 8 9}

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

You have previously taken elotuzumab in another study and are still benefiting from it, as decided by the doctor.

I am currently taking elotuzumab or other study drugs.

Exclusion Criteria

You were previously in a study with elotuzumab but had to stop for any reason.

I am not healthy enough for the study treatment, as decided by the doctor.

You did not get better from the treatment in a previous study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

4 weeks

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?

Group I: Elotuzumab Experimental Treatment 6 Interventions

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.

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

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

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

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

1. nature.com nature.com/articles/s41408-025-01310-z

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5013854/

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.

3. news.bms.com news.bms.com/news/details/2017/Four-Year-Follow-up-with-Empliciti-elotuzumab-Plus-LenalidomideDexamethasone-ELd-in-Patients-with-Advanced-Multiple-Myeloma-Shows-Long-term-Efficacy-in-ELOQUENT-2-Trial/default.aspx

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 ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa1505654

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 ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39449301/

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% ...

6. myeloma.org myeloma.org/empliciti-elotuzumab

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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/?otool=iaufhhslib&term=38494720

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%.

8. bmsaccesssupport.com bmsaccesssupport.com/empliciti/indications-important-safety-information

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 ...

9. news.bms.com news.bms.com/news/details/2015/New-Longer-Term-Data-for-Empliciti-elotuzumab-Showed-a-Continued-Progression-Free-Survival-Benefit-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx

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 ...