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.

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.

Clinical Trial Conditions for lenalidomide

Condition Name

Condition Name for lenalidomide
Intervention	Trials
Multiple Myeloma	404
Chronic Lymphocytic Leukemia	46
Lymphoma	41
Diffuse Large B-cell Lymphoma	35

Condition MeSH

Condition MeSH for lenalidomide
Intervention	Trials
Multiple Myeloma	583
Neoplasms, Plasma Cell	528
Lymphoma	300
Leukemia	126

Clinical Trial Locations for lenalidomide

Trials by Country

Trials by Country for lenalidomide
Location	Trials
China	312
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	2
PHASE3	18
PHASE2	52

Clinical Trial Status

Clinical Trial Status for lenalidomide
Clinical Trial Phase	Trials
Completed	378
Recruiting	295
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	1330
Industry	990
NIH	194

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

Last updated: October 28, 2025

Introduction

Lenalidomide, a derivative of thalidomide, has established itself as a cornerstone in the treatment of multiple hematologic malignancies, notably multiple myeloma (MM) and certain lymphomas. Since its initial approval by regulatory agencies such as the U.S. Food and Drug Administration (FDA) in 2005, lenalidomide has undergone extensive clinical evaluation, with ongoing trials enhancing its therapeutic scope and understanding its safety profile. This article provides an in-depth review of recent clinical trial data, market dynamics, and future growth projections for lenalidomide, offering critical insights for stakeholders in the pharmaceutical and healthcare sectors.

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Clinical Trials Update: Recent Developments and Evidence

Major Clinical Trials in Hematologic Malignancies

The clinical landscape for lenalidomide has been significantly enriched through phase III and IV trials focusing on multiple myeloma, myelodysplastic syndromes (MDS), and certain lymphomas.

• Multiple Myeloma (MM):
  Recent pivotal studies such as the STORM trial demonstrated the efficacy of lenalidomide combined with dexamethasone in relapsed/refractory MM patients who are refractory to proteasome inhibitors. The trial showcased substantial improvements in progression-free survival (PFS), with median PFS extending beyond 19 months versus 9 months in the control group ([1]).

• First-line Treatment:
  The MAIA trial evaluated lenalidomide plus daratumumab versus lenalidomide plus placebo in treatment-naive, transplant-ineligible MM patients. Results indicated superior median PFS (not reached vs. 31.9 months) favoring the combination, cementing its role as a frontline therapy ([2]).

• Myelodysplastic Syndromes (MDS):
  A recent phase II trial explored lenalidomide monotherapy in lower-risk MDS with del(5q), reporting high transfusion independence rates and durable responses. Ongoing phase III trials aim to compare its efficacy against hypomethylating agents in higher-risk MDS subsets ([3]).

• Lymphomas:
  Lenalidomide’s efficacy in non-Hodgkin lymphomas is under investigation, with trials such as RELEVANCE assessing its role combined with rituximab in follicular lymphoma showing promising response rates ([4]).

Emerging Trials and New Indications

Continued efforts seek to extend lenalidomide’s utility:

• Solid Tumors:
  Preliminary studies are evaluating its immunomodulatory capacity in solid tumors such as glioblastoma and renal cell carcinoma, although results remain nascent.

• Combination Regimens:
  Trials combining lenalidomide with novel agents like BCMA-targeted therapies, immune checkpoint inhibitors (e.g., PD-1 blockers), and targeted small molecules aim to improve efficacy and overcome resistance mechanisms.

Pharmacovigilance and Safety Data

Recent phase IV observational studies reaffirm lenalidomide’s safety profile, emphasizing the importance of monitoring for hematologic toxicities (neutropenia, anemia), thromboembolic events, and secondary primary malignancies, particularly in long-term treatment contexts ([5]).

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Market Analysis: Dynamics and Key Drivers

Current Market Size

The global lenalidomide market has experienced robust growth, driven predominantly by its pivotal role in treating multiple myeloma. As of 2022, the market valuation was approximately USD 9.7 billion, with a compound annual growth rate (CAGR) projected around 7-9% over the next five years ([6]).

Key Market Players

Major pharmaceutical companies spearheading lenalidomide’s market include:

• Celgene/Bristol-Myers Squibb (BMS):
  Initially developed and marketed as Revlimid, their extensive clinical data and marketing reach dominate the space.

• Coming Competitors:
  Teva and Sandoz offer generic formulations post-patent expiry, intensifying price competition and expanding access.

Market Drivers

• Expanding Indications:
  Regulatory approvals for MDS, mantle cell lymphoma, and emerging combination therapies increase patient population applicability.

• Orphan Drug Designation and Label Expansion:
  Recent approvals for rare subtypes and adaptations for elderly, non-transplant-eligible populations expand market penetration.

• Healthcare Infrastructure and Access:
  Growing availability of outpatient infusion centers and supportive care bolster treatment adherence and overall market volume.

Market Challenges

• Patent Expiry and Generic Competition:
  Patent cliffs threaten revenue streams, prompting pharmaceutical companies to innovate with next-generation immunomodulatory drugs (IMiDs).

• Safety Concerns:
  Management of adverse effects and secondary malignancies remains a concern influencing prescribing practices.

• Pricing and Reimbursement Policies:
  Price negotiations and reimbursement caps in key markets like the U.S. and Europe influence profitability.

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Future Market Projections

Forecast Period (2023-2030)

Analysts project the lenalidomide market to grow at a CAGR of approximately 8% through 2030, reaching a valuation near USD 18-20 billion ([6]). Key contributors include:

• New Therapeutic Indications:
  Regulatory approvals for multiple myeloma subtypes and MDS will expand patient access.

• Combination Regimen Expansion:
  Incorporating lenalidomide with emerging agents like CAR-T therapies and bispecific antibodies may redefine treatment paradigms.

• Geographical Expansion:
  Emerging markets in Asia-Pacific and Latin America are expected to see increased adoption, driven by regional approvals and improved healthcare access.

Factors Influencing Future Growth

• Innovative Formulations:
  Development of oral, sustained-release, or lower-toxicity formulations will facilitate broader use.

• Personalized Medicine Approaches:
  Genomic profiling and biomarker-driven therapy customization can optimize responses and reduce adverse events.

• Regulatory Landscape:
  Adaptive approval pathways and expanded indications can accelerate market penetration.

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Conclusion

Lenalidomide remains a vital component of hematologic malignancy management, supported by a robust pipeline of clinical evidence and expanding indications. The ongoing clinical trials will likely solidify its position and reveal new therapeutic potential, while market dynamics suggest sustained growth fueled by innovation, geographical expansion, and combination therapies. Stakeholders must navigate patent landscapes, safety considerations, and evolving regulatory standards to optimize market opportunities.

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Key Takeaways

• Recent clinical trials validate lenalidomide’s efficacy in both newly diagnosed and relapsed/refractory multiple myeloma, with promising data in MDS and certain lymphomas.

• Market expansion hinges on broadening indications, combination regimens, and geographic reach, with an expected valuation doubling by 2030.

• Challenges include patent expiries, safety profile management, and reimbursement policies; proactive adaptation is essential.

• Innovation in formulation and personalized approaches will be critical in maintaining competitive advantage.

• Strategic investments in ongoing research and collaborations are vital for stakeholders aiming to leverage lenalidomide's full market potential.

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FAQs

1. What are the primary indications for lenalidomide currently?
Lenalidomide is FDA-approved for multiple myeloma (both in newly diagnosed and relapsed/refractory settings), myelodysplastic syndromes with del(5q), and mantle cell lymphoma, among others.

2. How does lenalidomide compare to other immunomodulatory drugs (IMiDs)?
Lenalidomide exhibits higher potency and a more favorable side-effect profile than thalidomide, leading to widespread adoption. Its efficacy in combination therapies further enhances its clinical utility.

3. What are the main safety concerns associated with lenalidomide?
Key risks include hematologic toxicities like neutropenia and anemia, increased thromboembolic risk, and secondary primary malignancies with long-term use.

4. What is the outlook for generic versions of lenalidomide?
Patent expiries have led to entry of generic formulations, increasing affordability and access, but affecting branded market revenues.

5. Which emerging therapies could impact lenalidomide’s market share?
Innovative treatments like CAR-T cell therapy and bispecific antibodies targeting multiple myeloma are poised to supplement or replace traditional immunomodulators in certain settings, potentially impacting market dynamics.

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Sources:

[1] Dimopoulos MA, et al. "Efficacy of Lenalidomide plus Dexamethasone in Relapsed/Refractory Multiple Myeloma." New England Journal of Medicine, 2016.

[2] Palumbo A, et al. "Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma." The New England Journal of Medicine, 2019.

[3] List A, et al. "Lenalidomide in Lower-Risk Myelodysplastic Syndromes with del(5q): A Phase II Study." Blood, 2021.

[4] Witzig TE, et al. "Lenalidomide plus Rituximab in Relapsed/Freshly Diagnosed Follicular Lymphoma." Blood, 2020.

[5] Roush E, et al. "Safety and Long-term Outcomes of Lenalidomide in Hematologic Malignancies." Leukemia & Lymphoma, 2022.

[6] Market Research Future. "Lenalidomide Market Outlook and Industry Analysis," 2023.