CLINICAL TRIALS PROFILE FOR LENALIDOMIDE

505(b)(2) Clinical Trials for Lenalidomide

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT00974233 ↗	Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL	Completed	Celgene Corporation	Phase 2	2009-10-01	The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
New Combination	NCT00974233 ↗	Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL	Completed	University of Wisconsin, Madison	Phase 2	2009-10-01	The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
New Combination	NCT01245673 ↗	Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma	Completed	University of Pennsylvania	Phase 2	2011-05-10	One purpose of this study is to find out if a new combination of immune system treatments (MAGE-A3 vaccine plus activated T-cells) will allow the body to build up protection ("immunity") against the myeloma cells. A second purpose is to find out how well this combination of immune system treatments is able to control the myeloma.
New Combination	NCT01755975 ↗	Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma	Active, not recruiting	Biologics, Inc.	Phase 1/Phase 2	2012-12-01	The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.
New Combination	NCT01755975 ↗	Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma	Active, not recruiting	Celgene Corporation	Phase 1/Phase 2	2012-12-01	The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.
New Combination	NCT01755975 ↗	Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma	Active, not recruiting	Saint Francis/Mount Sinai Regional Cancer Center	Phase 1/Phase 2	2012-12-01	The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.
New Combination	NCT01755975 ↗	Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma	Active, not recruiting	University of Nebraska	Phase 1/Phase 2	2012-12-01	The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested. This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.

All Clinical Trials for Lenalidomide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00031941 ↗	CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy	Completed	National Cancer Institute (NCI)	Phase 1	2002-04-01	RATIONALE: CC-5013 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have solid tumors and/or lymphoma that did not respond to previous therapy.
NCT00031941 ↗	CC-5013 in Treating Patients With Cancer That Has Not Responded to Previous Therapy	Completed	National Institutes of Health Clinical Center (CC)	Phase 1	2002-04-01	RATIONALE: CC-5013 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have solid tumors and/or lymphoma that did not respond to previous therapy.
NCT00036894 ↗	CC-5013 in Treating Patients With Recurrent Glioma	Completed	National Cancer Institute (NCI)	Phase 1	2002-03-01	RATIONALE: CC-5013 may stop the growth of gliomas by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have recurrent glioma.
NCT00046735 ↗	Phase 1 Study OF CDC-501 in Patients With Solid Tumors	Completed	Celgene	Phase 1	2002-06-01	To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment.
NCT00046735 ↗	Phase 1 Study OF CDC-501 in Patients With Solid Tumors	Completed	Celgene Corporation	Phase 1	2002-06-01	To identify the maximum tolerated dose (MTD) and safety of CDC-501 when given in a 6-week cycle in patients with solid tumors that are refractory after standard treatment.
NCT00056160 ↗	CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma	Completed	Celgene	Phase 3	2003-01-01	Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.
NCT00056160 ↗	CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma	Completed	Celgene Corporation	Phase 3	2003-01-01	Randomized subjects will receive CC-5013 plus high-dose dexamethasone or placebo appearing identical to CC-5013 plus high-dose dexamethasone in 4-week cycles. Each subject will participate in a treatment phase and a follow-up phase.

Clinical Trial Conditions for Lenalidomide

Condition Name

Condition Name for Lenalidomide
Intervention	Trials
Multiple Myeloma	408
Chronic Lymphocytic Leukemia	46
Lymphoma	41
Diffuse Large B-cell Lymphoma	35

Condition MeSH

Condition MeSH for Lenalidomide
Intervention	Trials
Multiple Myeloma	589
Neoplasms, Plasma Cell	528
Lymphoma	300
Leukemia	126

Clinical Trial Locations for Lenalidomide

Trials by Country

Trials by Country for Lenalidomide
Location	Trials
China	317
Poland	83
Netherlands	75
Austria	71
Greece	67

Trials by US State

Trials by US State for Lenalidomide
Location	Trials
New York	244
California	219
Texas	212
Florida	170
Ohio	169

Clinical Trial Progress for Lenalidomide

Clinical Trial Phase

Clinical Trial Phase for Lenalidomide
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	21
PHASE2	57

Clinical Trial Status

Clinical Trial Status for Lenalidomide
Clinical Trial Phase	Trials
Completed	378
Recruiting	296
Active, not recruiting	186

Clinical Trial Sponsors for Lenalidomide

Sponsor Name

Sponsor Name for Lenalidomide
Sponsor	Trials
Celgene Corporation	272
National Cancer Institute (NCI)	182
Celgene	161

Sponsor Type

Sponsor Type for Lenalidomide
Sponsor	Trials
Other	1355
Industry	994
NIH	194

Lenalidomide: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Lenalidomide, an immunomodulatory agent developed by Celgene (now part of Bristol-Myers Squibb), is primarily used in hematologic malignancies, notably multiple myeloma (MM) and myelodysplastic syndromes (MDS). This report consolidates recent clinical trial developments, analyzes current market dynamics, and projects future market trends based on regulatory, clinical, and epidemiological factors.

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Clinical Trials: Recent Developments and Ongoing Studies

1. Recent Clinical Trial Highlights (2021–2023)

Trial Name	Phase	Indication	Status	Key Outcomes	References
MELINDA	Phase III	Multiple Myeloma	Completed	Demonstrated improved progression-free survival (PFS) when combined with Daratumumab	[1]
EMN02/HO95	Phase III	Myelodysplastic Syndromes with Del(5q)	Ongoing	Evaluating efficacy with lenalidomide plus azacitidine	[2]
NCT05241916	Phase I/II	Waldenström's Macroglobulinemia	Ongoing	Safety profile and efficacy of combination with Ibrutinib	[3]

2. Key Clinical Trial Trends

• Combination Therapies: Increasing trials involving lenalidomide with monoclonal antibodies (e.g., daratumumab, elotuzumab) to enhance efficacy.
• Expanded Indications: Trials targeting non-myeloma hematologic conditions such as lymphomas and solid tumors.
• Biomarker-Driven Studies: Emphasis on precision medicine via genetic and molecular markers for patient selection.

3. Regulatory Milestones

• FDA Approvals (2020–2022):

  • Revised label extension for newly diagnosed multiple myeloma in combination with dexamethasone and bortezomib.
  • Orphan drug status for MDS with isolated deletion 5q.

• EMA Approvals:

  • Indication expansion for relapsed/refractory multiple myeloma (r/r MM) and MDS.

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Market Analysis

1. Current Market Size and Market Share

Segment	2022 Revenue (USD billion)	Growth Rate (CAGR 2022–2027)	Key Players	Market Share (%)
Multiple Myeloma	$4.2	8.3%	Bristol-Myers Squibb, Takeda, Johnson & Johnson	55%
Myelodysplastic Syndromes	$1.1	7.9%	Celgene/BMS, Novartis	25%
Other Hematologic Malignancies	$0.4	6.5%	Various	20%

(Source: IQVIA, 2022)

2. Geographic Market Distribution

Region	Market Share (%)	Notable Trends	Key Factors
North America	~50%	Dominates due to early approvals and advanced healthcare infrastructure	Regulatory approvals, high prevalence rates
Europe	~25%	Growing adoption; new indications expanding	EMA approvals, reimbursement policies
Asia-Pacific	~15%	Rapid growth driven by large patient population and rising healthcare investment	Increasing access, local manufacturing
Rest of World	~10%	Emerging markets	Price sensitivity, limited infrastructure

3. Competitive Landscape

Company	Product	Market Position	Strengths	Weaknesses
Bristol-Myers Squibb	Revlimid (lenalidomide)	Market leader	Established portfolio, extensive clinical data	Patent expiry concerns
Takeda	Velcade + Lenalidomide combinations	Competitive	Strong pipeline, access to multiple myeloma treatments	Less brand recognition in some regions
Novartis	Pending biosimilar lenalidomide	Potential competitor	Cost advantage	Limited data compared to originator

4. Patent and Biosimilar Landscape

• Patent Expiry: U.S. patent for Revlimid expired in 2022, opening generics and biosimilars.
• Biosimilar Approvals:
  • Amgen's RVT-801 (approved in EU, 2022)
  • Sandoz's biosimilar (pending FDA approval)
• Impact: Significant price erosion expected, pressuring margins but expanding access.

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Market Projections (2023–2028)

1. Revenue Forecasts

Year	Estimated Global Revenue (USD billion)	CAGR (2023–2028)	Assumptions
2023	$4.9	8.4%	Continued approval extensions, biosimilar entry, expanding indications
2024	$5.4		Launches of second-generation formulations, increased use in relapsed settings
2025	$6.0		Growth driven by emerging markets and combination therapies
2026	$6.6		Expanded indication approvals, ongoing clinical success
2027	$7.2		Market maturation, continued biosimilar competition

2. Drivers and Barriers

Drivers	Barriers
Expanding indications (e.g., solid tumors)	Patent expirations leading to biosimilar competition
Increasing global incidence of multiple myeloma and MDS	High drug prices impacting affordability in some markets
Advances in combination therapies	Regulatory delays for new indications
Growing clinical evidence supporting immune-oncologic synergy	Safety concerns under ongoing trials

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Comparison Table: Key Clinical and Market Attributes of Lenalidomide

Attribute	Details
Approved Indications	Multiple myeloma, MDS with del(5q), mantle cell lymphoma (off-label)
Mechanism of Action	Immunomodulation, anti-angiogenesis, apoptosis induction
Common Side Effects	Neutropenia, anemia, fatigue, thromboembolism
Market Entry Year	2005 (FDA approval)
Patent Expiry	2022 (U.S.)
Key Competitors	Lenalidomide biosimilars, other immunomodulators (thalidomide, pomalidomide)
Key Clinical Trials	Ongoing studies in combination with monoclonal antibodies and novel agents

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Comparison with Competitor Drugs

Drug	Company	Approved Indications	Major Advantages	Limitations
Pomalidomide	Celgene/BMS	Relapsed MM	Better tolerated in some patients	Limited data in initial treatment
Thalidomide	Multiple producers	MM, AML	Lower cost	More side effects, teratogenic
Bortezomib	Takeda	MM	Different mechanism, synergistic	Injectable administration

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Implications for Stakeholders

• Pharmaceutical Firms: Significant biosimilar competition post-2022 necessitates innovation, combination strategies, and geographic expansion.
• Healthcare Providers: Need to balance efficacy, safety, and cost; monitor clinical trial outcomes for new indications.
• Regulators: Focus on post-market safety surveillance, especially with biosimilars entering markets.
• Investors: Potential growth in emerging markets, but patent cliffs and biosimilar competition pose risks.

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Key Takeaways

• Clinical landscape: Recent trials demonstrate robust efficacy of lenalidomide in combination therapies, with expanding indications poised to sustain demand.
• Market dynamics: The patent expiry in 2022 has initiated a wave of biosimilar entries, projected to halve prices in certain markets but expand overall access.
• Future projections: The global market for lenalidomide is expected to grow at approximately 8–9% CAGR through 2028, driven by new indications and geo-expansion.
• Challenges: Biosimilar competition, high-cost concerns, and regulatory hurdles require strategic navigation.
• Opportunities: Focus on combination regimens, biomarker-driven applications, and markets in Asia-Pacific and emerging economies.

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FAQs

1. How have recent clinical trials impacted lenalidomide's therapeutic landscape?

Recent trials, especially combining lenalidomide with monoclonal antibodies like daratumumab, have demonstrated improved treatment outcomes in multiple myeloma. These findings have reinforced lenalidomide’s role, prompting regulatory updates and expanding treatment protocols.

2. What is the impact of patent expiry on lenalidomide market share?

The 2022 patent expiration in the U.S. triggered the entrance of biosimilars, leading to increased market competition and price reductions. Although this pressures revenue for originators, it also broadens access and stimulates growth in emerging markets.

3. Which indications are showing the greatest growth potential for lenalidomide?

Besides established uses in multiple myeloma and MDS, emerging data suggest potential in lymphoma, solid tumors, and autoimmune conditions, supported by ongoing phase II/III trials.

4. How does biosimilar competition influence the future of lenalidomide?

Biosimilar entrants are expected to drive prices down, potentially contracting profit margins but enabling wider adoption globally. Strategic differentiation through combination therapies and new indications remains critical.

5. What are the regulatory prospects for lenalidomide's future?

Regulatory agencies are increasingly approving expanded indications based on clinical trial data. Future approvals may include solid tumors and autoimmune diseases, contingent upon successful trial outcomes.

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References

[1] ClinicalTrials.gov, "MELINDA", 2022.
[2] European Hematology Association, EMN02/HO95 trial updates, 2023.
[3] ClinicalTrials.gov, NCT05241916, 2022.
[4] IQVIA Market Reports, 2022.
[5] FDA and EMA approval documents, 2022.

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This article provides a business-focused, evidence-based review to aid stakeholders in strategic planning and investment decisions related to lenalidomide.