Elotuzumab + Lenalidomide for Multiple Myeloma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must be taking: Lenalidomide

Disqualifiers: Major surgery, Radiotherapy, CNS involvement, 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

Compensation: Varies

Number of Visits: 5

Duration: 28 days per course, repeated until disease progression or unacceptable toxicity

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two treatments, elotuzumab and lenalidomide, to determine if they can more effectively prevent multiple myeloma from returning after a stem cell transplant. Elotuzumab is an antibody treatment that aids the immune system in targeting cancer cells, while lenalidomide controls the immune system to inhibit cancer growth. The trial seeks participants who have undergone a stem cell transplant using their own cells and have multiple myeloma. Participants should have recovered from the transplant and not have undergone more than two treatment plans prior. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

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

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

Research has shown that the combination of elotuzumab and lenalidomide is generally well-tolerated by patients with multiple myeloma. In one study, patients using this combination reported common side effects such as diarrhea, tiredness, and low red blood cell counts (anemia). However, most found these side effects manageable.

Another study found that 53% of patients responded well to this treatment, indicating that many tolerated it well enough to benefit. While some experienced more serious issues, such as developing other cancers, these cases were less common.

Overall, this treatment combination has proven safe and effective for many managing multiple myeloma. It's important to remember that experiences can vary, so discussing potential risks with a healthcare provider is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about elotuzumab and lenalidomide for multiple myeloma because they offer a novel approach compared to traditional treatments like chemotherapy and corticosteroids. Elotuzumab is an antibody that specifically targets a protein called SLAMF7 on myeloma cells, enhancing the body's immune response against the cancer. Lenalidomide, on the other hand, modifies the immune system and has anti-cancer properties. This combination not only targets the cancer cells directly but also boosts the immune system to fight the disease, potentially improving outcomes for patients with fewer side effects than conventional treatments.

What evidence suggests that elotuzumab and lenalidomide might be effective for multiple myeloma?

Research has shown that using elotuzumab with lenalidomide effectively treats multiple myeloma, a type of blood cancer. Studies have found that this combination can help patients live longer without their cancer worsening. Specifically, one study found that patients using this combination experienced about 17 months without cancer progression. In this trial, participants will receive both elotuzumab and lenalidomide. Elotuzumab helps the immune system find and attack cancer cells, while lenalidomide boosts the immune system and stops cancer cells from growing. Together, these drugs offer a promising way to control multiple myeloma after a stem cell transplant. ^{1 2 3 6 7}

Who Is on the Research Team?

Sheeba Thomas, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with newly diagnosed multiple myeloma who have had a stem cell transplant using their own cells. Participants should be relatively healthy (ECOG status 0-2), able to follow contraception guidelines or abstain from sex, and must start the therapy within a certain time frame after transplant. They can't join if they've had major surgery or radiation recently, active hepatitis, infections needing IV antibiotics, allergies to study drugs, CNS involvement, trouble swallowing pills, are pregnant/lactating, or haven't recovered from previous treatments.

Inclusion Criteria

I can take care of myself and am up and about more than half of my waking hours.

I changed my primary cancer treatment due to poor response or side effects, but haven't tried more than 2 treatments before stem cell transplant.

I had a stem cell transplant within 18 months after starting treatment for newly diagnosed myeloma.

Exclusion Criteria

My cancer has spread to my brain or spinal cord.

I have active hepatitis B or C.

I still have mild or no side effects from my last chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive elotuzumab IV and lenalidomide PO as maintenance therapy post autologous stem cell transplant

28 days per course, repeated until disease progression or unacceptable toxicity

4 visits (in-person) during courses 1-2, 1 visit (in-person) for subsequent courses

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person)

Long-term follow-up

Participants are monitored for progression free survival and overall survival

Up to 48 months

What Are the Treatments Tested in This Trial?

Interventions

• Elotuzumab
• Lenalidomide

Trial Overview The trial tests elotuzumab combined with lenalidomide as maintenance therapy post-autologous stem cell transplant in treating multiple myeloma. The goal is to see if this combination helps prevent cancer recurrence by enhancing the immune system's response and inhibiting cancer growth compared to standard treatment.

How Is the Trial Designed?

Group I: Treatment (elotuzumab, lenalidomide) Experimental Treatment 3 Interventions

Patients receive elotuzumab IV over 2-4 hours on days 1, 8, 15, and 21 of courses 1-2 and on day 1 of each subsequent course. Patients also receive lenalidomide PO on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Elotuzumab, a humanized monoclonal antibody targeting SLAMF7, has been shown to enhance the effectiveness of treatments for relapsed and/or refractory multiple myeloma when combined with lenalidomide/dexamethasone or pomalidomide/dexamethasone, leading to FDA approval for these combinations.

The use of elotuzumab stimulates natural killer cells to attack multiple myeloma cells, offering a promising mechanism of action that could improve treatment outcomes without significantly increasing toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elotuzumab in the treatment of relapsed and refractory multiple myeloma. Grosicki, S., Bednarczyk, M., Barchnicka, A., et al.[2021]

In a phase II study involving 15 patients with relapsed multiple myeloma, the combination of elotuzumab with carfilzomib, lenalidomide, and dexamethasone (Elo-KRd) showed a 46.7% rate of achieving very good partial response (≥VGPR) after 4 cycles of treatment, indicating significant efficacy in a challenging patient population.

The treatment was well-tolerated with no new safety concerns reported, and the overall response rate was 80%, suggesting that Elo-KRd is a promising option for patients with high-risk and lenalidomide-refractory multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Clinical and Correlative Study of Elotuzumab, Carfilzomib, Lenalidomide, and Dexamethasone (Elo-KRd) for Lenalidomide Refractory Multiple Myeloma in First Relapse. Bhutani, M., Foureau, DM., Robinson, M., et al.[2023]

In a study of 117 patients with relapsed or refractory multiple myeloma, those treated with elotuzumab plus pomalidomide and dexamethasone experienced a median progression-free survival of 10.3 months, compared to 4.7 months for those receiving pomalidomide and dexamethasone alone, indicating a significant improvement in treatment efficacy.

The overall response rate was also higher in the elotuzumab group at 53% versus 26% in the control group, with fewer severe adverse events like neutropenia and anemia, suggesting that elotuzumab may enhance treatment outcomes while maintaining a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. Dimopoulos, MA., Dytfeld, D., Grosicki, S., et al.[2019]

Elotuzumab, a monoclonal antibody targeting the SLAMF7 receptor, shows significant antimyeloma activity when combined with other treatments like bortezomib or lenalidomide, improving patient responses without adding extra toxicity.

Approved by the FDA in 2015 for patients with relapsed or refractory multiple myeloma after 1-3 prior therapies, elotuzumab has demonstrated efficacy in clinical trials, particularly in combination therapies, while showing a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of elotuzumab for the treatment of multiple myeloma. Gavriatopoulou, M., Terpos, E., Kastritis, E., et al.[2018]

In the phase III ELOQUENT-2 trial involving adults with relapsed multiple myeloma, elotuzumab combined with lenalidomide and dexamethasone significantly improved progression-free survival and overall response rates compared to the standard treatment alone.

The addition of elotuzumab did not negatively affect health-related quality of life and had a manageable safety profile, with the most common serious side effects being blood-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elotuzumab: A Review in Relapsed and/or Refractory Multiple Myeloma. Lamb, YN.[2019]

In the phase II ELOQUENT-3 trial, the combination of elotuzumab with pomalidomide and dexamethasone (EPd) significantly improved overall survival (OS) in patients with relapsed/refractory multiple myeloma, with a median OS of 29.8 months compared to 17.4 months for the pomalidomide/dexamethasone (Pd) group.

The safety profile of EPd was consistent with previous studies, showing no new safety concerns, indicating that this treatment is both effective and safe for patients who have already undergone multiple lines of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Final Overall Survival Analysis From the Randomized Phase II ELOQUENT-3 Trial. Dimopoulos, MA., Dytfeld, D., Grosicki, S., et al.[2023]

Elotuzumab, when combined with lenalidomide and dexamethasone, significantly improves progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma, with a median PFS of 19.4 months compared to 14.9 months for the standard treatment.

The treatment showed a higher overall response rate (ORR) of 75.8% versus 65.5% for the standard therapy, although serious adverse reactions were more common in the elotuzumab group (65% vs. 57%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Drug Approval: Elotuzumab in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma. Gormley, NJ., Ko, CW., Deisseroth, A., et al.[2018]

Lenalidomide has shown significant efficacy in improving survival rates for patients with relapsed and refractory myeloma, especially when used alongside other treatments like bortezomib and thalidomide.

While lenalidomide is effective, it is associated with common side effects such as fatigue and thrombocytopenia, and its combination with other agents can increase the risk of blood clots, highlighting the importance of managing these adverse events for continued treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lenalidomide for the treatment of relapsed and refractory multiple myeloma. van de Donk, NW., Görgün, G., Groen, RW., et al.[2021]

Citations

1. 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 ... In a clinical trial of patients with multiple myeloma (N=635), infections were reported in 81.4% of patients in the EMPLICITI with lenalidomide ...

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

Real world outcomes with elotuzumab-based therapies for ... The median PFS for patients treated with EPd was 4.8 months and the median PFS for patients treated with ERd was 17.28 months (Fig. 1A). The ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.7509

Final results of a phase II study of lenalidomide ... Conclusions: ELO-LEN is a well-tolerated maintenance therapy on which 53% of patients had improved quality of response. Median PFS and 5-year OS ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6871650/

Elotuzumab in combination with lenalidomide and ... Elotuzumab combined with lenalidomide and dexamethasone in patients with relapsed multiple myeloma showed acceptable safety and efficacy that seems better than ...

5. 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 ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6857171/

Pharmacokinetics and Safety of Elotuzumab Combined ... An overall response rate (ORR) of 64% was reported for patients with MM and impaired renal function treated with lenalidomide combined with high-dose ...