CLINICAL TRIALS PROFILE FOR EMPLICITI

All Clinical Trials for EMPLICITI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01729091 ↗	Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma	Active, not recruiting	Celgene	Phase 2	2013-06-10	This phase II trial studies the side effects and best dose of umbilical cord blood-derived natural killer cells when given together with elotuzumab, lenalidomide, and high dose melphalan before autologous stem cell transplant and to see how well they work in treating patients with multiple myeloma. Before transplant, stem cells are taken from patients and stored. Immunotherapy with monoclonal antibodies, such as elotuzumab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and melphalan, may work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving natural killer cells from donor umbilical cord blood before transplant may also kill myeloma cells that remain in the body after the last chemotherapy treatment. After treatment, stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
NCT01729091 ↗	Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2013-06-10	This phase II trial studies the side effects and best dose of umbilical cord blood-derived natural killer cells when given together with elotuzumab, lenalidomide, and high dose melphalan before autologous stem cell transplant and to see how well they work in treating patients with multiple myeloma. Before transplant, stem cells are taken from patients and stored. Immunotherapy with monoclonal antibodies, such as elotuzumab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and melphalan, may work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving natural killer cells from donor umbilical cord blood before transplant may also kill myeloma cells that remain in the body after the last chemotherapy treatment. After treatment, stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
NCT01729091 ↗	Umbilical Cord Blood-Derived Natural Killer Cells, Elotuzumab, Lenalidomide, and High Dose Melphalan, Followed by Stem Cell Transplant in Treating Patients With Multiple Myeloma	Active, not recruiting	M.D. Anderson Cancer Center	Phase 2	2013-06-10	This phase II trial studies the side effects and best dose of umbilical cord blood-derived natural killer cells when given together with elotuzumab, lenalidomide, and high dose melphalan before autologous stem cell transplant and to see how well they work in treating patients with multiple myeloma. Before transplant, stem cells are taken from patients and stored. Immunotherapy with monoclonal antibodies, such as elotuzumab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide and melphalan, may work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving natural killer cells from donor umbilical cord blood before transplant may also kill myeloma cells that remain in the body after the last chemotherapy treatment. After treatment, stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.
NCT02420860 ↗	Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma	Active, not recruiting	Bristol-Myers Squibb	Phase 2	2015-04-14	This phase II trial studies how well elotuzumab works when given with lenalidomide as maintenance therapy after transplant in patients with newly diagnosed multiple myeloma who underwent transplant using their own stem cells (autologous transplant). Maintenance therapy is treatment that is given to help keep cancer from coming back after it has disappeared following the initial treatment. Immunotherapy with monoclonal antibodies, such as elotuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Adding elotuzumab to standard maintenance therapy with lenalidomide may work better in treating patients with multiple myeloma who have undergone transplant.

Clinical Trial Conditions for EMPLICITI

Condition Name

Condition Name for EMPLICITI
Intervention	Trials
Multiple Myeloma	14
Relapsed Refractory Multiple Myeloma	3
Myeloma	3
Plasma Cell Myeloma	2

Condition MeSH

Condition MeSH for EMPLICITI
Intervention	Trials
Multiple Myeloma	20
Neoplasms, Plasma Cell	19
Leukemia, Myeloid, Acute	1
Leukemia, Plasma Cell	1

Clinical Trial Locations for EMPLICITI

Trials by Country

Trials by Country for EMPLICITI
Location	Trials
United States	52
Canada	4
Belgium	1
Italy	1
Spain	1

Trials by US State

Trials by US State for EMPLICITI
Location	Trials
Missouri	6
New York	5
Texas	5
Colorado	4
Michigan	4

Clinical Trial Progress for EMPLICITI

Clinical Trial Phase

Clinical Trial Phase for EMPLICITI
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	14
Phase 1/Phase 2	2

Clinical Trial Status

Clinical Trial Status for EMPLICITI
Clinical Trial Phase	Trials
Active, not recruiting	7
Not yet recruiting	4
Withdrawn	3

Clinical Trial Sponsors for EMPLICITI

Sponsor Name

Sponsor Name for EMPLICITI
Sponsor	Trials
Bristol-Myers Squibb	13
National Cancer Institute (NCI)	4
Multiple Myeloma Research Consortium	4

Sponsor Type

Sponsor Type for EMPLICITI
Sponsor	Trials
Other	33
Industry	22
NIH	4

Clinical Trials Update, Market Analysis, and Projection for EMPLICITI

Last updated: November 4, 2025

Introduction

EMPLICITI (elotuzumab) is a monoclonal antibody developed by Bristol-Myers Squibb (BMS) for the treatment of multiple myeloma. Since its FDA approval in 2016, the drug has occupied a niche in the myeloma treatment landscape, primarily in relapsed or refractory settings. This report provides a comprehensive update on EMPLICITI's clinical trial landscape, current market performance, and future market projections, emphasizing its evolving role amid competitive therapies.

Clinical Trials Update

Current Clinical Trial Landscape

EMPLICITI's clinical development has centered predominantly on combination therapies for multiple myeloma. The drug's mechanism—targeting SLAMF7 (signaling lymphocytic activation moleculeF7)—complements existing treatment regimens by enhancing immune-mediated cytotoxicity against malignant plasma cells.

As of 2023, over 20 clinical trials involving EMPLICITI are registered on ClinicalTrials.gov, focusing on:

• Combination regimens with immunomodulatory drugs (IMiDs) and proteasome inhibitors.
• Earlier lines of therapy inclusion, aiming to expand its use beyond the relapsed/refractory setting.
• New indications, including smoldering myeloma and other plasma cell dyscrasias, though these are in early phases.

Key Clinical Trial Outcomes

• Efficacy in Combination Therapies: The pivotal Phase III ELOQUENT-2 trial demonstrated that combining EMPLICITI with lenalidomide and dexamethasone improved progression-free survival (PFS) in relapsed multiple myeloma patients, with an acceptable safety profile. This established EMPLICITI as part of combination regimens for relapsed cases [1].

• Myeloma Treatment in Transplant Candidates: Trials assessing EMPLICITI as induction therapy pre- and post-stem cell transplantation are ongoing, but conclusive results are pending.

• Investigational Uses: Early-phase trials are exploring EMPLICITI's efficacy in smoldering myeloma and possibly other plasma cell disorders, with initial data suggesting tolerability but requiring confirmation of efficacy.

Regulatory Progress and Development Challenges

Although EMPLICITI gained FDA approval in combination with lenalidomide and dexamethasone, its development has faced challenges:

• Limited Monotherapy Promise: Monotherapy trials yielded modest responses, emphasizing the drug's role within combination protocols rather than as a standalone therapy.

• Competitive Landscape: The proliferation of novel agents, including CAR-T therapies (e.g., idecabtagene vicleucel) and bispecific antibodies (e.g., teclistamab), has shifted the clinical trial focus toward these emerging modalities, possibly overshadowing EMPLICITI's further development.

Despite this, BMS continues to evaluate EMPLICITI's potential in expanding indications and optimizing existing regimens.

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Market Analysis

Market Overview

Multiple myeloma remains a significant therapeutic challenge, with a global market size projected to grow at a CAGR of over 12% through 2028 [2]. EMPLICITI occupies a niche, primarily targeting relapsed/refractory multiple myeloma (RRMM), where it competes with several other monoclonal antibodies (e.g., daratumumab, isatuximab).

Current Market Position

• Sales Performance: Post-approval, EMPLICITI's sales have been modest. In 2022, BMS reported global sales of approximately USD 150 million, reflecting its limited penetration relative to larger competitors [3].

• Market Penetration Factors:

  • Pricing and reimbursement hurdles
  • Competitive alternatives offering broader mechanisms of action
  • Limited monotherapy efficacy, relegating EMPLICITI largely to combination regimens.

• Geographical Reach: The drug is primarily marketed in North America and select European countries, with emerging presence in Asian markets.

Competitive Environment

EMPLICITI faces competition chiefly from:

• Anti-CD38 monoclonal antibodies: Daratumumab and isatuximab have higher market shares due to broader approvals and demonstrated monotherapy efficacy.
• Emerging modalities: CAR-T therapies and bispecific T-cell engagers targeting BCMA are gaining traction, offering potentially more potent and durable responses.

Market Barriers

• Physician Preference & Experience: Clinicians tend to prefer therapies with proven monotherapy activity and data supporting maintenance therapy.
• Pricing Dynamics: Cost considerations influence treatment selection, especially in healthcare systems with constrained budgets.

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Market Projection

Short-term Outlook (2023–2025)

• Stable but limited growth is expected for EMPLICITI, supported by incremental adoption within combination regimens for RRMM.
• Sales forecast: Estimated to reach USD 200–250 million annually, driven by increased use in earlier lines and expanded combination options [4].

Medium to Long-term Outlook (2026–2030)

• Expansion into earlier treatment lines and combination regimens could catalyze growth but will likely be constrained by competition from novel agents.
• Innovative formulations or new indications: Potential development of subcutaneous formulations or trials in plasma cell disorders could provide growth catalysts.
• Market share erosion: Anticipated due to rapid advancement and adoption of CAR-T and bispecific antibodies, translating into a plateau or slight decline in EMPLICITI revenues unless differentiated positioning is achieved.

Factors Influencing Market Dynamics

• Regulatory approvals for new indications or formulations.
• Efficacy and safety profiles compared with emerging therapies.
• Cost-effectiveness: Demonstrating value similar or superior to competitors will be pivotal.
• Reimbursement landscape: Favorable coverage policies will accelerate adoption.

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Key Takeaways

• Clinical Development:

  • EMPLICITI remains a valuable component of combination therapy for relapsed multiple myeloma.
  • Ongoing trials in earlier lines and investigation into new indications may bolster its clinical relevance.

• Market Position and Performance:

  • Its current market share is limited but holds steady within niche combinations.
  • Competition from immunotherapies and cell-based therapies is intensifying, challenging EMPLICITI's dominance.

• Future Market Potential:

  • Modest growth prospects predominate through expanded combination treatments and potential new formulations.
  • Strategic positioning focused on superior safety profiles, cost-effectiveness, and exploring broader indications could enhance its market trajectory.

• Strategic Considerations:

  • Continuous monitoring of competitive developments is essential.
  • Collaborations or combination innovations could improve clinical and market outcomes.
  • Cost management and demonstrating value will be key in expanding payer and patient acceptance.

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FAQs

1. What are the primary clinical indications for EMPLICITI?
EMPLICITI is approved for use in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma, particularly when other options have been exhausted.

2. How does EMPLICITI compare to other monoclonal antibodies in multiple myeloma?
While EMPLICITI targets SLAMF7 and shows efficacy in combination regimens, drugs like daratumumab (anti-CD38) have broader approval indications, including monotherapy, and higher market penetration, limiting EMPLICITI's comparative reach.

3. Are there ongoing trials exploring new uses for EMPLICITI?
Yes, ongoing trials are assessing EMPLICITI's role in earlier lines of therapy, as maintenance therapy post-transplant, and in other plasma cell disorders, though definitive benefits remain under investigation.

4. What are the main competitive threats to EMPLICITI in the myeloma market?
Emerging therapies such as CAR-T cell treatments (e.g., idecabtagene vicleucel), bispecific antibodies, and other immunomodulatory agents pose significant competition, especially considering their promising efficacy and expanding indications.

5. What factors will influence EMPLICITI's future market success?
Key factors include clinical trial outcomes demonstrating superior or comparable efficacy, regulatory approvals for new indications or formulations, favorable reimbursement policies, and its ability to carve a distinct niche amid an expanding therapeutic landscape.

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References

[1] Lonial S, et al. "Elotuzumab plus lenalidomide and dexamethasone in relapsed multiple myeloma." N Engl J Med. 2015;373(7):621-631.
[2] Fortune Business Insights. "Multiple Myeloma Treatment Market Size, Share & Industry Analysis". 2022.
[3] Bristol-Myers Squibb Annual Report 2022.
[4] Evaluate Pharma. "World Preview 2023: Outlook to 2028".