CLINICAL TRIALS PROFILE FOR REVLIMID

505(b)(2) Clinical Trials for REVLIMID

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.

All Clinical Trials for REVLIMID

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00067743 ↗	A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)	Completed	Celgene Corporation	Phase 2	2003-08-01	This is a multicenter, open-label study in adult subjects with Type 1 Complex Regional Pain Syndrome. Subjects diagnosed with unilateral Type 1 CRPS will be enrolled sequentially to receive CC-5013 10 mg/day orally. For each subject the study consists of two phases: Pre-treatment phase(1 wk) and treatment phase (12 wks)
NCT00087672 ↗	A Phase II Study of CC-5013 in Myelofibrosis	Completed	Celgene Corporation	Phase 2	2004-07-01	The goal of this clinical research study is to learn if CC-5013 (lenalidomide) can help to control myelofibrosis. The safety of lenalidomide in the treatment of myelofibrosis will also be studied.
NCT00087672 ↗	A Phase II Study of CC-5013 in Myelofibrosis	Completed	M.D. Anderson Cancer Center	Phase 2	2004-07-01	The goal of this clinical research study is to learn if CC-5013 (lenalidomide) can help to control myelofibrosis. The safety of lenalidomide in the treatment of myelofibrosis will also be studied.
NCT00093028 ↗	Study of Bortezomib and Revlimid™ for Patients Relapsing or Progressing on Total Therapy II	Completed	University of Arkansas	Phase 3	2004-01-01	The purpose of this study is - to find out the effects of treating patients with two new chemotherapy drugs (bortezomib and Revlimid™), - to study how many patients' myeloma responds to treatment on this study, and how many patients survive after this treatment, - to learn if a patient's genetic makeup before and after treatment can predict which patients will respond to bortezomib and Revlimid™, and to learn more about how the body responds (gene array studies).
NCT00098475 ↗	Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2004-10-26	This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide, thalidomide, and dexamethasone together may kill more cancer cells.

Clinical Trial Conditions for REVLIMID

Condition Name

Condition Name for REVLIMID
Intervention	Trials
Multiple Myeloma	144
Chronic Lymphocytic Leukemia	33
Plasma Cell Myeloma	26
Lymphoma	24

Condition MeSH

Condition MeSH for REVLIMID
Intervention	Trials
Multiple Myeloma	234
Neoplasms, Plasma Cell	228
Lymphoma	141
Leukemia	85

Clinical Trial Locations for REVLIMID

Trials by Country

Trials by Country for REVLIMID
Location	Trials
Canada	135
France	77
Spain	68
Germany	67
Italy	64

Trials by US State

Trials by US State for REVLIMID
Location	Trials
Texas	117
California	112
New York	111
Ohio	92
Florida	83

Clinical Trial Progress for REVLIMID

Clinical Trial Phase

Clinical Trial Phase for REVLIMID
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	1
Phase 4	5

Clinical Trial Status

Clinical Trial Status for REVLIMID
Clinical Trial Phase	Trials
Completed	222
Active, not recruiting	97
Terminated	91

Clinical Trial Sponsors for REVLIMID

Sponsor Name

Sponsor Name for REVLIMID
Sponsor	Trials
Celgene Corporation	185
National Cancer Institute (NCI)	135
Celgene	105

Sponsor Type

Sponsor Type for REVLIMID
Sponsor	Trials
Other	530
Industry	486
NIH	138

Clinical Trials Update, Market Analysis, and Projection for Revlimid

Last updated: October 28, 2025

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Introduction

Revlimid (lenalidomide) remains a pivotal agent in the oncology therapeutics landscape, particularly in hematology. Approved initially by the FDA in 2005 for multiple myeloma, its indications have expanded to include myelodysplastic syndromes (MDS) and mantle cell lymphoma (MCL). As a derivative of thalidomide, Revlimid’s efficacy derives from immunomodulatory and anti-angiogenic properties, positioning it as a cornerstone in multiple myeloma management.

This comprehensive analysis synthesizes recent clinical trial updates, evaluates the current market dynamics, and projects future trajectories for Revlimid, offering actionable insights for stakeholders across the pharmaceutical ecosystem.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Revlimid continues to be investigated through numerous clinical trials, both as a monotherapy and in combination regimens, aiming to refine its use in hematologic malignancies and explore novel indications.

• Multiple Myeloma (MM):
  Numerous trials are evaluating Revlimid in combination with agents like daratumumab, bortezomib, and elotuzumab. The ELOQUENT-2 trial (NCT01568866), which demonstrated benefit in relapsed/refractory MM, remains pivotal, with ongoing follow-ups assessing long-term outcomes.

• Myelodysplastic Syndromes (MDS):
  Several studies focus on Revlimid’s role in lower-risk MDS. The MDS-003 trial demonstrated its efficacy in transfusion-dependent patients with deletion 5q cytogenetic abnormality, with subsequent trials examining optimizing dosing and duration.

• Mantle Cell Lymphoma (MCL):
  Trials such as L-MIND (NCT03664666) evaluate Revlimid combined with monoclonal antibodies, showing promising response rates in relapsed MCL.

• Emerging Indications:
  Investigations include its use in diffuse large B-cell lymphoma (DLBCL) and certain solid tumors, although these are preliminary phases.

Key Clinical Trial Updates in 2022–2023

• Combination Regimens:
  Recent phase 3 trials demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) with Revlimid-based combinations in multiple myeloma. The MAIA trial confirmed the superiority of lenalidomide plus daratumumab over lenalidomide alone in transplant-ineligible patients.

• Biomarker-Driven Approaches:
  Several trials are integrating genomic and molecular markers to personalize therapy, such as minimal residual disease (MRD) status assessments in MM.

• Adverse Event Management:
  Newer studies focus on optimizing dosing schedules and supportive care to mitigate adverse effects like cytopenias, secondary malignancies, and thromboembolic events.

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Market Analysis

Current Market Landscape

Revlimid held a dominant position within the hematology-oncology pipeline, with global sales peaking at approximately $12.3 billion in 2022 (reported by Celgene/Bristol-Myers Squibb). Its patent exclusivity, notably the uspatent expiry in 2026, has been a significant factor in revenue generation.

Key market segments include:

• Multiple Myeloma:
  Constitutes the largest portion of revenue, driven by its incorporation into frontline and relapsed settings.

• MDS:
  A growing segment, especially for patients with deletion 5q abnormality.

• Lymphomas:
  Smaller but expanding, particularly with combination treatments.

Patent Expiry and Biosimilar Competition

The impending patent expiry in the U.S. and Europe in 2026 poses significant strategic challenges. Biosimilar and generic versions are already in development, with several candidates entering Phase 3 biosimilar trials (e.g., Amgen, Cipla, and Celltrion).

In response, Bristol-Myers Squibb (BMS) and partner companies are exploring:

• Value-added combinations to extend market share.
• Expanded indications with ongoing trials.
• Pricing strategies to maintain competitiveness.

Market Drivers

• Increasing Incidence of Hematological Malignancies:
  Rising global cancer prevalence (notably in aging populations) fuels demand.

• Regulatory Approvals for New Indications:
  Successful trial outcomes can lead to expanded labels, augmenting market share.

• Patient Access Programs:
  Price reductions and assistance initiatives improve penetration, especially in emerging markets.

Market Challenges

• Patent Cliffs:
  Will catalyze generic entry, leading to potential revenue erosion.

• Adverse Event Profiles:
  Cardiovascular risks and secondary malignancies necessitate vigilant monitoring, potentially impacting prescribing habits.

• Pricing Pressures:
  Payers and healthcare systems seek cost-effective alternatives, especially post-patent expiry.

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Future Market Projections

Growth Trajectory (2023–2030)

Despite looming generic competition, Revlimid's global market is projected to sustain a compound annual growth rate (CAGR) of approximately 3-5% up to 2030, driven by:

• Novel combination regimens enhancing efficacy and expanding indications.
• Relapsed/refractory patient populations that remain reliant on Revlimid-based therapies.
• The potential approval of biosimilars which, while eroding margins, may sustain volume sales.

Impact of Biosimilars

Biosimilar introduction is predicted to:

• Reduce overall prices by 30-50%.
• Accelerate access in low- and middle-income countries.
• Shift revenue streams from original makers to biosimilar producers, affecting profit margins but potentially increasing volume.

Emerging Therapeutic Strategies

• Cellular therapies (e.g., CAR T-cells):
  May impact Revlimid’s role in multiple myeloma management, especially in earlier lines, though currently they complement rather than replace it.

• Next-generation Immunomodulatory Drugs (IMiDs):
  Development of drugs with improved safety profiles could modify the competitive landscape.

Regional Market Dynamics

• North America:
  Continues to dominate, supported by high healthcare expenditure and high disease prevalence.

• Europe:
  Growth is steady but constrained by pricing pressures and patent expiries.

• Asia-Pacific:
  Expected to see the fastest expansion due to increasing diagnosis rates, expanding healthcare infrastructure, and rising awareness.

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Key Takeaways

• Revlimid remains a cornerstone in hematology-oncology, with ongoing trials promising to expand its indications and optimize its use.
• Patent expiration in 2026 will introduce biosimilar competition, necessitating strategic diversification, including novel combinations and indications.
• Market sustainability hinges on clinical efficacy, safety profile management, and geographic expansion into emerging markets.
• Investments in biomarker-driven therapies and personalized medicine could extend Revlimid’s lifecycle and improve patient outcomes.
• Stakeholders should prepare for pricing and access strategies aligned with biosimilar entry, emphasizing value-based care.

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FAQs

1. What is the primary current indication for Revlimid?
   The predominant use of Revlimid is in the treatment of multiple myeloma, both as monotherapy and in combination with other agents, in newly diagnosed and relapsed settings.

2. How will patent expiry affect Revlimid’s market?
   The U.S. and European patents are set to expire in 2026, leading to the entry of biosimilars, which will likely reduce prices and market share for the original product but expand access globally.

3. Are there ongoing trials exploring new indications for Revlimid?
   Yes, trials are examining Revlimid’s efficacy in other hematologic malignancies like DLBCL and various solid tumors, though these are in early phases.

4. What strategies are companies employing to extend Revlimid’s market viability?
   Strategies include expanding indications, developing high-value combination therapies, optimizing dosing schedules, and entering broader geographic markets.

5. What are the main safety concerns associated with Revlimid?
   Risks include thromboembolic events, cytopenias, secondary malignancies, and teratogenicity, which require careful patient monitoring and management.

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References

[1] Celgene/Bristol-Myers Squibb Annual Report 2022.
[2] ClinicalTrials.gov Database.
[3] Industry reports on hematology drug markets, 2022–2023.
[4] Food and Drug Administration (FDA). Revlimid approval documents.
[5] Market Research Future. Hematologic malignancies market analysis.

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This detailed overview provides a strategic perspective on Revlimid, equipping stakeholders with insights to navigate clinical developments, competitive pressures, and future growth opportunities.