Elotuzumab + Triple Therapy for Multiple Myeloma

Not currently recruiting at 422 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Southwest Oncology Group

Must not be taking: Zidovudine, Stavudine

Disqualifiers: Non-secretory MM, Amyloidosis, POEMS, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new combination therapy for multiple myeloma, a cancer affecting plasma cells in the bone marrow. The study evaluates how well elotuzumab (Empliciti) works with lenalidomide, bortezomib, and dexamethasone to slow or stop cancer growth. Patients with newly diagnosed multiple myeloma that is likely to return or spread, especially those with certain high-risk factors, might be suitable candidates. Interested participants should have active multiple myeloma and no prior chemotherapy for Phase I, and only one cycle of non-investigational chemotherapy for Phase II. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering patients a chance to contribute to groundbreaking cancer therapy development.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that elotuzumab, when combined with other drugs, has been tested in patients with multiple myeloma. In these studies, some patients experienced a reduced risk of disease progression. However, about 9% or fewer patients developed new types of cancer, known as second primary malignancies.

Lenalidomide, bortezomib, and dexamethasone are already used to treat multiple myeloma, and much is known about their safety. These drugs can sometimes cause side effects such as tiredness, low blood counts, and an increased risk of infections, but most patients tolerate them well.

Overall, this suggests that the combination treatment might be relatively safe, though known risks exist. Participants in trials should be aware of these risks and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatment involving elotuzumab for multiple myeloma because it offers a novel approach by enhancing the immune system's ability to target cancer cells. Unlike standard treatments like bortezomib, lenalidomide, and dexamethasone, which mainly target the cancer cells directly, elotuzumab works by activating the body's natural killer cells to recognize and attack the myeloma cells. This dual approach of combining immune activation with direct cancer cell targeting could potentially improve treatment efficacy and provide a more comprehensive attack on the disease. This innovative mechanism is why this combination therapy is generating interest in the medical community.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

In this trial, participants will receive different treatment combinations. In Arm I, patients will receive the standard treatment of bortezomib, lenalidomide, and dexamethasone. In Arm II, elotuzumab will be added to this standard treatment. Previous studies have shown that adding elotuzumab to lenalidomide and dexamethasone provides clear benefits for patients with multiple myeloma, reducing the risk of the disease worsening by 27% and extending the period without disease progression. Real-world data supports these findings, indicating that patients using elotuzumab-based treatments lived longer. Elotuzumab directly targets cancer cells and helps the body's immune system attack them. Overall, these findings suggest that elotuzumab, along with the other drugs, could be a promising option for treating high-risk multiple myeloma. ^{1 2 6 7 8}

Who Is on the Research Team?

Saad Usmani

Principal Investigator

SWOG Cancer Research Network

Are You a Good Fit for This Trial?

This trial is for newly diagnosed high-risk multiple myeloma patients without prior malignancies, except certain treated cases. They must not have POEMS syndrome or CNS involvement by MM, and should meet specific blood count and organ function criteria. Women of childbearing age need a negative pregnancy test and agreed birth control measures. Participants must consent to specimen banking for research.

Inclusion Criteria

I do not have POEMS syndrome.

My multiple myeloma has not spread to my brain or spinal cord.

I have hepatitis B or C but meet specific viral load criteria.

Exclusion Criteria

I am HIV+ and meet all required health criteria for the study.

I do not have non-secretory multiple myeloma or amyloidosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Patients receive bortezomib, lenalidomide, and dexamethasone, with or without elotuzumab, in repeated 21-day cycles for 8 courses

24 weeks

Multiple visits per cycle for drug administration

Maintenance

Patients continue treatment with bortezomib, lenalidomide, and dexamethasone, with or without elotuzumab, in repeated 28-day cycles

Until disease progression or unacceptable toxicity

Monthly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 years

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Bortezomib
• Dexamethasone
• Elotuzumab
• Lenalidomide

Trial Overview The study tests if adding Elotuzumab to the combination of Lenalidomide, Bortezomib, and Dexamethasone improves treatment outcomes in high-risk multiple myeloma patients. It's a phase I/II trial that also aims to determine the best dose with acceptable side effects.

How Is the Trial Designed?

Group I: Arm II (bortezomib, lenalidomide, dexamethasone, elotuzumab) Experimental Treatment 5 Interventions

INDUCTION: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1, 8, and 15 of courses 1 and 2 and on days 1 and 11 of courses 3-8. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive bortezomib, lenalidomide, and dexamethasone as in Arm I. Patients also receive elotuzumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (bortezomib, lenalidomide, dexamethasone) Active Control 4 Interventions

INDUCTION: Patients receive bortezomib SC or IV on days 1, 4, 8, and 11; lenalidomide PO QD on days 1-14; and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity (patients who received a course of chemotherapy prior to registration will begin protocol treatment with course 2 and receive a total of 7 courses of protocol therapy). MAINTENANCE: Patients receive bortezomib SC or IV on days 1, 8, and 15; lenalidomide PO QD on days 1-21; and dexamethasone PO on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in United States as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in Canada as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in Japan as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

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 ... The most common AEs (all grades) in ELd and Ld, respectively, were diarrhea (49%, 38%), fatigue (48%, 41%), anemia (43%, 38%), pyrexia (40%, 25 ...

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

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 ...

5. 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 ...

6. 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 ...

7. aetna.com aetna.com/cpb/medical/data/800_899/0899.html

Elotuzumab (Empliciti) - Medical Clinical Policy Bulletins Newly Diagnosed Multiple Myeloma​​ Although pre-clinical data looked very promising, elotuzumab monotherapy did not result in objective clinical responses in ...

8. 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 ...