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	377
Chronic Lymphocytic Leukemia	45
Lymphoma	40
Plasma Cell Myeloma	31

Condition MeSH

Condition MeSH for Lenalidomide
Intervention	Trials
Multiple Myeloma	545
Neoplasms, Plasma Cell	527
Lymphoma	296
Leukemia	126

Clinical Trial Locations for Lenalidomide

Trials by Country

Trials by Country for Lenalidomide
Location	Trials
Belgium	88
Poland	68
Austria	67
Korea, Republic of	66
Netherlands	59

Trials by US State

Trials by US State for Lenalidomide
Location	Trials
New York	239
California	211
Texas	207
Ohio	165
Florida	164

Clinical Trial Progress for Lenalidomide

Clinical Trial Phase

Clinical Trial Phase for Lenalidomide
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	147
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for Lenalidomide
Clinical Trial Phase	Trials
Completed	377
Recruiting	236
Active, not recruiting	186

Clinical Trial Sponsors for Lenalidomide

Sponsor Name

Sponsor Name for Lenalidomide
Sponsor	Trials
Celgene Corporation	270
National Cancer Institute (NCI)	179
Celgene	160

Sponsor Type

Sponsor Type for Lenalidomide
Sponsor	Trials
Other	1261
Industry	941
NIH	191

Lenalidomide: Clinical Trials, Market Analysis, and Projections

Introduction to Lenalidomide

Lenalidomide, marketed under the brand name Revlimid, is a potent immunomodulatory drug used primarily in the treatment of multiple myeloma, myelodysplastic syndromes, and certain types of lymphoma. Its efficacy and versatility have made it a cornerstone in the treatment of various blood cancers.

Clinical Trials Update

STAR-LLD Phase 1b Clinical Trial

A significant development in the clinical trials of lenalidomide is the STAR-LLD Phase 1b trial conducted by Starton Therapeutics. This trial assessed the safety, pharmacokinetics, and efficacy of continuous subcutaneous (SC) infusion of low-dose lenalidomide in combination with dexamethasone and bortezomib (Velcade®) for multiple myeloma (MM) patients. The interim results showed a 100% partial response or better in all six patients within 1-3 cycles, indicating lower toxicity at therapeutic doses compared to traditional oral administration of lenalidomide[1][5].

Lenalidomide in Smoldering Multiple Myeloma

Another notable trial is the randomized phase II/III study at UCSF, which compares lenalidomide treatment to observation in patients with asymptomatic high-risk smoldering multiple myeloma. This trial aims to assess the response to therapy, response rate, time to progression, and overall survival between the treatment and observation groups. It also evaluates the incidence of adverse events in patients receiving lenalidomide for early-stage multiple myeloma[4].

Market Analysis

Current Market Size and Growth

The global lenalidomide market has experienced strong growth in recent years. As of 2023, the market size was valued at USD 10.39 billion and is expected to grow to USD 10.86 billion in 2024. The market is projected to reach USD 15.67 billion by 2032, with a compound annual growth rate (CAGR) of 4.7% during the forecast period[2][5].

Drivers of Market Growth

Several factors are driving the growth of the lenalidomide market:

• Increasing Cancer Cases: The rising incidence of blood cancers worldwide is a significant driver. According to the American Cancer Society 2023 Report, there will be an estimated 1,958,310 new cancer cases in the United States alone, emphasizing the need for effective treatments like lenalidomide[2].
• Pharmaceutical Initiatives: Pharmaceutical companies are expanding their brand coverage and introducing new strengths of lenalidomide, such as the 2.5 mg and 20 mg strengths introduced by Natco Pharma in the United States[2].
• Generic Versions: The approval of generic lenalidomide capsules, such as those by Sun Pharma, is expected to increase the supply and accessibility of the drug in the global market[2].
• Research and Development: Ongoing research and development activities, including the exploration of new administration methods like subcutaneous infusion, are expected to drive new growth opportunities for lenalidomide[5].

Market Projections

Future Market Size

The lenalidomide market is expected to continue its strong growth trajectory. By 2028, the market size is projected to reach USD 16.29 billion, with a CAGR of 8.2% during the forecast period. This growth is attributed to several factors, including increased regulatory approvals for expanded indications, growing demand for targeted therapies, and emerging market adoption[3].

Market Segmentation

The lenalidomide market is segmented based on type, application, end-user, dosage, and region. This segmentation helps in understanding the diverse needs and trends within the market. For instance, the market is segmented into different dosages (5mg, 10mg, 15mg, 25mg) and applications (multiple myeloma, myelodysplastic syndromes, lymphoma), which are critical for tailoring treatment strategies and market strategies[2][3].

Challenges and Limitations

Despite the positive outlook, there are several challenges that could impact the growth of the lenalidomide market:

• Side Effects: Lenalidomide is associated with several side effects, including an irregular heartbeat, thrombosis, chest pain, and bleeding gums. These side effects could negatively impact its adoption[5].
• Higher Development Costs: The initial costs of drug development and competition from generic medicines are expected to hinder the market growth in the long run[5].

Emerging Trends

Combination Therapies

There is a heightened focus on combination therapies, with lenalidomide often being used in conjunction with other drugs like dexamethasone and bortezomib. This trend is expected to continue, driven by the improved efficacy and reduced toxicity observed in clinical trials[1][3].

Personalized Medicine

The growing demand for personalized medicine approaches is another trend. Research is ongoing to tailor lenalidomide treatment to individual patient needs, which could enhance its effectiveness and reduce side effects[3].

Real-World Evidence

There is an increasing emphasis on real-world evidence in treatment decisions. This involves using data from real-world settings to inform treatment strategies, which could further optimize the use of lenalidomide[3].

Key Takeaways

• Positive Clinical Trials: The STAR-LLD Phase 1b trial has shown promising results with continuous subcutaneous infusion of lenalidomide.
• Market Growth: The global lenalidomide market is expected to reach USD 15.67 billion by 2032, driven by increasing cancer cases and pharmaceutical initiatives.
• Segmentation: The market is segmented by type, application, end-user, dosage, and region, which helps in understanding diverse market needs.
• Challenges: Side effects and higher development costs are potential limitations to market growth.
• Emerging Trends: Combination therapies, personalized medicine, and real-world evidence are key trends shaping the future of lenalidomide treatment.

FAQs

What is the current market size of the lenalidomide market?

The current market size of the lenalidomide market was valued at USD 10.39 billion in 2023[2].

What is the projected growth rate of the lenalidomide market?

The lenalidomide market is expected to grow at a CAGR of 4.7% during the forecast period from 2024 to 2032[2].

What are the primary applications of lenalidomide?

Lenalidomide is primarily used in the treatment of multiple myeloma, myelodysplastic syndromes, and certain types of lymphoma[2].

What are the side effects associated with lenalidomide?

Lenalidomide is associated with side effects such as an irregular heartbeat, thrombosis, chest pain, and bleeding gums[5].

Are there any ongoing clinical trials for lenalidomide?

Yes, there are ongoing clinical trials, including the STAR-LLD Phase 1b trial and the UCSF trial comparing lenalidomide to observation in smoldering multiple myeloma[1][4].

Sources

1. Starton Therapeutics Announces 100% Partial Response or Better in Top-Line STAR-LLD Phase 1b Data. Starton Therapeutics.
2. Lenalidomide Market Expects $15.67 Billion By 2032, CAGR: 4.7%. Polaris Market Research.
3. Global Lenalidomide Market Report 2024. The Business Research Company.
4. Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma. ClinicalTrials.gov.
5. Lenalidomide Market Growth Analysis By 2024-2032. Polaris Market Research.