Elo-Pom-Dex for Multiple Myeloma

Not currently recruiting at 4 trial locations

Overseen By Ravi Vij, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must be taking: Pomalidomide

Must not be taking: Investigational agents

Disqualifiers: Peripheral neuropathy, 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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of three drugs—elotuzumab, pomalidomide, and dexamethasone—to determine if they can improve outcomes for people with multiple myeloma, a type of blood cancer, after their second stem cell transplant. The goal is to assess whether this combination can prevent the cancer from returning or worsening. The trial seeks participants whose multiple myeloma returned after their first transplant and who have completed their second one. As a Phase 2 trial, the 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 if you need to stop taking your current medications. However, you cannot be on other investigational agents within 14 days before joining the trial.

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

Research shows that the combination of elotuzumab, pomalidomide, and dexamethasone is generally well-tolerated by patients with multiple myeloma. Studies have found that this treatment remains effective for patients whose disease has returned or worsened after other treatments.

Importantly, research suggests that this combination is not only effective but also manageable in everyday settings, meaning patients outside controlled clinical trials have handled the treatment without major problems. One study highlighted the potential of this combination, showing it can be effective without causing severe side effects.

Overall, evidence supports that this treatment is safe and manageable for patients, even those who have undergone multiple myeloma treatments before. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments for multiple myeloma?

Researchers are excited about the Elo-Pom-Dex combination treatment for multiple myeloma because it offers a unique approach by combining three powerful drugs: elotuzumab, pomalidomide, and dexamethasone. Unlike many standard treatments that primarily focus on chemotherapy, elotuzumab targets a specific protein called SLAMF7 on myeloma cells, enhancing the immune system's ability to fight the cancer. Pomalidomide, an immunomodulatory agent, works alongside by boosting the immune response further, while dexamethasone helps reduce inflammation and enhance the effectiveness of the other drugs. This multi-faceted attack on multiple myeloma could potentially lead to improved outcomes for patients who have not responded well to traditional therapies.

What evidence suggests that the Elo-Pom-Dex treatment could be effective for multiple myeloma?

Research has shown that the combination of elotuzumab, pomalidomide, and dexamethasone, which participants in this trial will receive, effectively treats multiple myeloma, particularly in patients unresponsive to other treatments. Studies have found this treatment to be active and generally well-tolerated, aiding in managing the disease in patients whose multiple myeloma has returned or is resistant to treatment. Pomalidomide targets cancer cells that resist other drugs, and adding elotuzumab enhances the treatment's effectiveness, leading to longer-lasting results. Overall, these findings suggest that this treatment combination has strong potential to improve outcomes for patients after a second stem cell transplant. ^{1 2 3 4 5}

Who Is on the Research Team?

Ravi Vij, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with relapsed multiple myeloma after a first stem cell transplant. They must have failed 1 or 2 treatment lines, received specific induction therapy before a second transplant, and be responding to current treatment. Participants need proper organ function and can't join if they're pregnant, breastfeeding, have severe neuropathy, other active cancers or infections, heart issues, uncontrolled illnesses or are sensitive to the drugs tested.

Inclusion Criteria

Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document

I have been diagnosed with multiple myeloma through a tissue test.

I've had 2-6 rounds of initial treatment before my second stem cell transplant.

Exclusion Criteria

My condition worsened on elotuzumab/pomalidomide or within 2 months after stopping it.

I am allergic to pomalidomide, dexamethasone, or components in elotuzumab.

Receiving any other investigational agents within 14 days prior to enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Patients receive 2-6 cycles of salvage/induction therapy per standard of care

Varies based on cycles

Second Autologous Stem Cell Transplantation

Patients undergo standard of care ASCT with melphalan conditioning

Continuation Therapy

Continuation therapy with Elo-Pom-Dex begins between Days 80 and 120 following the second ASCT and continues until relapse or progression

Until relapse or progression

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years post completion of treatment

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Elotuzumab
• Pomalidomide

Trial Overview The study tests whether adding Elotuzumab (a monoclonal antibody) to Pomalidomide (an immunomodulatory drug) and Dexamethasone (a steroid), known as Elo-Pom-Dex regimen, improves outcomes in patients receiving their second autologous stem cell transplantation for multiple myeloma.

How Is the Trial Designed?

Group I: Elotuzumab + Pomalidomide + Dexamethasone Experimental Treatment 3 Interventions

* Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study. * Following induction, patients will undergo standard of care ASCT melphalan conditioning (ASCT). Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol. * Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT: * 10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+ * 2 mg pomalidomide daily on Days 1-21 of all cycles * 40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+ * Continuation therapy may continue until relapse or progression.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Bristol-Myers Squibb

Industry 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

Celgene

Industry Sponsor

Trials

649

Recruited

130,000+

Top Products

>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Published Research Related to This Trial

In a phase 3 trial involving 455 patients with refractory or relapsed multiple myeloma, pomalidomide combined with low-dose dexamethasone significantly improved progression-free survival and overall survival compared to high-dose dexamethasone.

The treatment was effective across all patient subgroups, regardless of their previous treatments, and showed no cross-resistance with prior therapies, making it a strong candidate for standard care in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma. San Miguel, JF., Weisel, KC., Song, KW., et al.[2022]

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]

Elotuzumab combined with pomalidomide and dexamethasone (E-Pd) was shown to effectively prolong progression-free survival (PFS) in patients with relapsed and refractory multiple myeloma (RRMM), based on data from 440 patients in the ELOQUENT-3 study.

The pharmacokinetics of elotuzumab were well-characterized, revealing that its exposure did not lead to an increase in severe adverse events (grade 3+ AEs), indicating a favorable safety profile when used with the Pd regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma. Ide, T., Osawa, M., Sanghavi, K., et al.[2022]

Pomalidomide, when combined with low-dose dexamethasone, significantly improves progression-free survival and overall survival in adults with relapsed and refractory multiple myeloma, based on results from multinational phase II and III studies involving patients who had undergone at least two prior treatments.

The treatment has a manageable safety profile, with the most common serious side effects being neutropenia, infections, anemia, and thrombocytopenia, making it a viable option for patients with limited treatment alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pomalidomide: A Review in Relapsed and Refractory Multiple Myeloma. Hoy, SM.[2018]

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]

Pomalidomide, combined with low-dose dexamethasone, has been shown to be effective in treating adult patients with relapsed and refractory multiple myeloma, significantly improving progression-free survival and overall response rates compared to high-dose dexamethasone.

The treatment demonstrated a manageable safety profile and was effective across various patient subgroups, including those who were refractory to previous therapies, indicating its potential as a valuable salvage therapy option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pomalidomide: a review of its use in patients with recurrent multiple myeloma. Scott, LJ.[2022]

Citations

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

The Real-World Outcomes of Relapsed/Refractory Multiple ... The results of our study suggest that EPd is an active and well-tolerated regimen in RRMM, even in real-world patients.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1805762

Elotuzumab plus Pomalidomide and Dexamethasone for ... This trial showed the therapeutic potential of a second elotuzumab-based combination therapy for relapsed or refractory multiple myeloma.

3. nature.com nature.com/articles/s41408-024-01134-3

Phase II trial of elotuzumab with pomalidomide and ... We present the results of a prospective phase II study evaluating the efficacy of EPd in patients who have progressed after a prior daratumumab-containing ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03030261

Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom ... Adding elotuzumab may increase efficacy and also the durability of responses which is essential to improving outcomes following second ASCT. Official Title. A ...

5. ashpublications.org ashpublications.org/bloodadvances/article/9/5/1163/534297/Elotuzumab-in-combination-with-pomalidomide

Elotuzumab in combination with pomalidomide, bortezomib ... Elotuzumab combined with PVd is a novel, 4 drug combination in relapsed MM. The regimen is tolerated well and effective in patients with a ...