Elo-Pom-Dex for Multiple Myeloma

Recruiting at 3 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

25 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug combination of elotuzumab, pomalidomide, and dexamethasone for treating multiple myeloma?

Research shows that the combination of elotuzumab, pomalidomide, and dexamethasone is effective for patients with multiple myeloma, especially those who have not responded to other treatments. Studies found that this combination can prolong the time patients live without the disease getting worse and improve overall survival rates. ^{1 2 3 4 5}

Is the Elo-Pom-Dex treatment generally safe for humans?

The combination of elotuzumab, pomalidomide, and dexamethasone has been shown to be generally safe in patients with relapsed and refractory multiple myeloma, with manageable side effects. Common side effects include low blood cell counts, infections, and anemia, but these are typically manageable with medical supervision. ^{1 2 3 4 6}

What makes the drug Elo-Pom-Dex unique for treating multiple myeloma?

Elo-Pom-Dex combines elotuzumab, an antibody that helps the immune system target cancer cells, with pomalidomide and dexamethasone, which are effective in patients whose multiple myeloma has not responded to other treatments. This combination is particularly beneficial for patients with relapsed or refractory multiple myeloma, offering a new option when other therapies have failed. ^{1 2 3 4 6}

What is the purpose of this trial?

Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT, the natural next step is to evaluate maintenance/continuation therapy following second ASCT. Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide, making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab may increase efficacy and also the durability of responses which is essential to improving outcomes following second ASCT.

Research Team

Ravi Vij, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Elotuzumab plus Pomalidomide and Dexamethasone for Multiple Myeloma. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

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

3. New Zealand pubmed.ncbi.nlm.nih.gov

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

4. New Zealand pubmed.ncbi.nlm.nih.gov

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

5. Italy 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. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma. [2022]