CLINICAL TRIALS PROFILE FOR ELOTUZUMAB

All Clinical Trials for elotuzumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00726869 ↗	A Phase 1/2, Multi-center, Open-label, Dose-escalation Study of Elotuzumab(Humanized Anti-CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies.	Terminated	Bristol-Myers Squibb	Phase 1	2008-05-01	This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate the combination of elotuzumab and bortezomib in subjects with MM following 1 to 3 prior therapies. For the Phase 1 portion, elotuzumab will be administered by intravenous (IV) infusion at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes following the administration of bortezomib at 1.3 mg/m^2 IV bolus. Bortezomib will be given in 21 day cycles (twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest period). Elotuzumab will be administered as a separate infusion within 30 minutes following bortezomib administration on the same days as the first and last dose of each bortezomib cycle (i.e., Days 1 and 11).
NCT00726869 ↗	A Phase 1/2, Multi-center, Open-label, Dose-escalation Study of Elotuzumab(Humanized Anti-CS1 Monoclonal IgG1 Antibody) and Bortezomib in Subjects With Multiple Myeloma Following One to Three Prior Therapies.	Terminated	Abbott	Phase 1	2008-05-01	This Phase 1/2, multi-center, open-label, multiple-dose, dose escalation study will evaluate the combination of elotuzumab and bortezomib in subjects with MM following 1 to 3 prior therapies. For the Phase 1 portion, elotuzumab will be administered by intravenous (IV) infusion at up to 4 dose levels ranging from 2.5 mg/kg to 20.0 mg/kg within 30 minutes following the administration of bortezomib at 1.3 mg/m^2 IV bolus. Bortezomib will be given in 21 day cycles (twice weekly for 2 weeks on Days 1, 4, 8, and 11 followed by a 10-day rest period). Elotuzumab will be administered as a separate infusion within 30 minutes following bortezomib administration on the same days as the first and last dose of each bortezomib cycle (i.e., Days 1 and 11).
NCT00742560 ↗	A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple Myeloma	Completed	Bristol-Myers Squibb	Phase 2	2008-08-01	The purpose of this study is to evaluate the combination of elotuzumab, lenalidomide, and dexamethasone in subjects with relapsed multiple myeloma.
NCT00742560 ↗	A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple Myeloma	Completed	AbbVie (prior sponsor, Abbott)	Phase 2	2008-08-01	The purpose of this study is to evaluate the combination of elotuzumab, lenalidomide, and dexamethasone in subjects with relapsed multiple myeloma.
NCT01239797 ↗	Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma	Completed	AbbVie	Phase 3	2011-06-20	The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).
NCT01239797 ↗	Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma	Completed	Bristol-Myers Squibb	Phase 3	2011-06-20	The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).

Clinical Trial Conditions for elotuzumab

Condition Name

Condition Name for elotuzumab
Intervention	Trials
Multiple Myeloma	49
Multiple Myeloma in Relapse	4
Myeloma	4
Refractory Multiple Myeloma	3

Condition MeSH

Condition MeSH for elotuzumab
Intervention	Trials
Multiple Myeloma	66
Neoplasms, Plasma Cell	59
Recurrence	5
Leukemia	1

Clinical Trial Locations for elotuzumab

Trials by Country

Trials by Country for elotuzumab
Location	Trials
United States	411
Japan	56
Canada	51
Germany	25
Spain	21

Trials by US State

Trials by US State for elotuzumab
Location	Trials
New York	23
California	20
Massachusetts	19
Michigan	18
Florida	17

Clinical Trial Progress for elotuzumab

Clinical Trial Phase

Clinical Trial Phase for elotuzumab
Clinical Trial Phase	Trials
PHASE3	2
PHASE1	2
Phase 4	1

Clinical Trial Status

Clinical Trial Status for elotuzumab
Clinical Trial Phase	Trials
Active, not recruiting	17
Recruiting	16
Not yet recruiting	12

Clinical Trial Sponsors for elotuzumab

Sponsor Name

Sponsor Name for elotuzumab
Sponsor	Trials
Bristol-Myers Squibb	39
AbbVie	10
Celgene	10

Sponsor Type

Sponsor Type for elotuzumab
Sponsor	Trials
Industry	83
Other	65
NIH	6

Clinical Trials Update, Market Analysis, and Projection for Elotuzumab

Last updated: November 3, 2025

Introduction

Elotuzumab (trade name: Empliciti), developed by Bristol-Myers Squibb, is a monoclonal antibody targeting SLAMF7 (signaling lymphocytic activation molecule F7), approved primarily for the treatment of multiple myeloma. Since its approval in 2015, elotuzumab’s clinical path and market potential have evolved in response to ongoing trials, competitive landscape shifts, and unmet medical needs in hematologic malignancies. This comprehensive analysis synthesizes recent clinical trial developments, current market positioning, and future projections, offering strategic insights for stakeholders.

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Clinical Trials Update

Recent and Ongoing Trials

Elotuzumab’s development trajectory reflects a strategic focus on combination therapies rather than monotherapy, owing to its limited efficacy as a single agent in multiple myeloma. Several notable clinical trials have advanced the understanding of its utility:

1. ELOQUENT-2 (Phase III) – Confirmed Standard of Care
   This pivotal trial evaluated elotuzumab combined with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone. Results demonstrated significant improvements in progression-free survival (PFS) and overall response rates (ORR), leading to FDA approval in 2015.
   Current Status: The combination remains the standard in relapsed/refractory multiple myeloma (RRMM).

2. ELOQUENT-3 (Phase III) – Novel Combinations
   Recently, the ELOQUENT-3 trial assessed elotuzumab plus pomalidomide and dexamethasone in refractory disease. While results are preliminary, they suggest potential efficacy extending beyond initial indications, especially for heavily pretreated populations.
   Status: Results awaited peer-reviewed publication; regulatory considerations ongoing.

3. Frontline and Maintenance Trials
   Novel ongoing trials explore elotuzumab in frontline settings, including ELOQUENT-4, which studies its addition to pembrolizumab and other agents in newly diagnosed multiple myeloma. Maintenance therapy studies also investigate its role post-induction.

4. Other Hematological Malignancies
   There is limited activity in non-myeloma indications. Nonetheless, early-phase studies examine SLAMF7 expression across multiple hematologic conditions to identify new targets.

Emerging Data and Innovations

• Biomarker-driven predictions: Research indicates that high SLAMF7 expression corresponds with better responses, guiding patient stratification.
• New formulations: Liposomal or antibody-drug conjugate variants are under investigation to enhance efficacy and reduce toxicity.

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Market Analysis

Current Market Position

Elotuzumab’s market is notably niche, with primary sales stemming from its approved combination therapy for RRMM. The drug’s approval has been reinforced by its tolerability and synergistic effects:

• Market Size: The multiple myeloma market surpassed $19 billion globally in 2022, with the relapsed/refractory segment accounting for a significant share.
• Sales Performance: In 2022, elotuzumab generated approximately $300-400 million in worldwide sales, reflecting its established role in combination regimens [1].

Competitive Landscape

Elotuzumab operates amid intense competition from other monoclonal antibodies and novel agents:

• Daratumumab (Darzalex): A CD38 antibody with broader indications and higher efficacy in some settings.
• Isatuximab: Another anti-CD38 antibody with comparable efficacy.
• Emerging Therapies: CAR-T cell therapies (e.g., idecabtagene vicleucel), bispecific T-cell engagers, and novel oral agents are reshaping treatment paradigms.

Market Challenges

• Limited monotherapy efficacy: Restricts use outside combination regimens.
• Competitive efficacy: Some newer agents demonstrate superior response rates.
• Pricing and reimbursement pressures: As more options emerge, pricing dynamics intensify.

Future Market Projections

The outlook for elotuzumab is cautiously optimistic, contingent on ongoing trial success and labeling expansions. Key factors influencing future growth include:

• Regulatory approvals for new indications and combinations: Positive data could extend its use. For instance, potential approval for frontline or maintenance therapy would expand its addressable market.
• Biomarker personalization: Improving patient selection could enhance efficacy projections.
• Pricing strategies: Staying competitive amid newer therapies will be crucial.

Market analysts project a compound annual growth rate (CAGR) of approximately 2-3% for elotuzumab’s sales over the next five years, driven mostly by expansion into earlier lines of therapy and combination regimens [2].

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Impact of Regulatory Developments

Regulatory agencies appear cautiously optimistic about elotuzumab, given its established safety profile and incremental efficacy data. Future approvals or label updates could significantly influence sales. The European Medicines Agency (EMA) has maintained approval for the existing indications, with potential expansions pending positive trial outcomes.

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Strategic Implications

Healthcare stakeholders should monitor the following:

• Ongoing clinical results, especially from trial ELOQUENT-4 and similar studies.
• Competitive advances from CAR-T and bispecific antibodies.
• Regulatory signals for new indications or combination approvals.
• Cost-effectiveness data, influencing payer and clinician adoption.

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Conclusion

Elotuzumab remains a relevant player within the multiple myeloma therapeutic landscape, mainly as part of combination regimens in relapsed/refractory disease. While competition and evolving treatment paradigms challenge its market share, promising experimental data and potential label expansions provide avenues for growth. Its future success hinges on clinical trial outcomes, strategic positioning, and industry innovation in MM therapies.

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Key Takeaways

• Clinical development continues, with trials exploring broader uses and novel combinations.
• The drug’s current market is stable but faces intense competition from newer therapies.
• Growth projections remain modest but positive if ongoing trials yield favorable results and regulatory support.
• Stakeholders should focus on biomarker-driven strategies and positioning within combination regimens.
• Elotuzumab’s comparative advantage lies in its safety profile and established clinical efficacy in specific treatment settings.

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FAQs

1. What is elotuzumab primarily approved for?
   It is approved for use in combination with lenalidomide and dexamethasone in relapsed/refractory multiple myeloma.

2. Are there ongoing efforts to expand elotuzumab’s indications?
   Yes. Trials like ELOQUENT-4 are assessing its role in frontline settings, and others are investigating combination therapies with novel agents.

3. How does elotuzumab compare to other monoclonal antibodies for multiple myeloma?
   While effective, its efficacy is generally comparable or slightly behind newer anti-CD38 antibodies like daratumumab, with less aggressive marketing and broader indications.

4. What are the main challenges facing elotuzumab’s market growth?
   Competition from emerging therapies, limited efficacy as monotherapy, and pricing pressures restrict expansion.

5. What is the future outlook for elotuzumab?
   If clinical trials demonstrate significant benefits and regulatory approvals expand its indications, elotuzumab could regain a more prominent position in MM treatment protocols.

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References

[1] Bristol-Myers Squibb. (2022). Empliciti (Elotuzumab) Sales Data.

[2] Market Research Future. (2023). Multiple Myeloma Therapeutics Market Analysis and Forecast.