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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR THALOMID


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All Clinical Trials for Thalomid

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004635 ↗ Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer Completed Columbia University Phase 3 2000-03-01 This multi-center study will evaluate whether thalidomide can improve the effectiveness of the drugs leuprolide or goserelin in treating testosterone-dependent prostate cancer. Leuprolide and goserelin-both approved to treat prostate cancer-reduce testosterone production, which, in most patients, reduces the size of the tumor. Thalidomide, a drug used for many years to treat leprosy, blocks the growth of blood vessels that may be important to disease progression. Patients 18 years or older with testosterone-dependent prostate cancer that has persisted or recurred after having had surgery, radiation therapy, or cryosurgery, but whose disease has not metastasized (spread beyond the prostate) may be eligible for this study. Candidates are screened with a medical history and physical examination, including blood tests, bone and computed tomography (CT) scans or other imaging studies. Study participants are randomly assigned to one of two treatment groups. One group receives leuprolide or goserelin followed by thalidomide; the other receives leuprolide or goserelin followed by placebo (a look-alike pill with no active ingredients). Patients in both groups receive an injection of leuprolide or goserelin once a month for 6 months. After that time they take four capsules of either thalidomide or placebo once a day and remain on the drug until their prostate-specific antigen (PSA) level returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower.(PSA is a protein secreted by the prostate gland. Monitoring changes in levels of this protein can help evaluate tumor progression). At this point the entire procedure begins again, starting with leuprolide or goserelin treatment, but the experimental drug is switched; patients originally treated with thalidomide are crossed over to placebo, and patients originally treated with placebo are crossed over to thalidomide. Patients are monitored periodically with the following tests and procedures: Medical histories and physical examinations. Blood and urine tests to monitor thalidomide and PSA levels, the response to treatment, and routine laboratory values (e.g., cell counts and kidney and liver function). Computed tomography (CT) and bone scans, and possibly other imaging tests to assess the tumor. Electromyography (EMG) and nerve conduction studies, as needed. For electromyography, a thin needle is inserted into a few muscles and the patient is asked to relax or to contract the muscles.
NCT00004635 ↗ Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer Completed Holy Cross Hospital, Fort Lauderdale Phase 3 2000-03-01 This multi-center study will evaluate whether thalidomide can improve the effectiveness of the drugs leuprolide or goserelin in treating testosterone-dependent prostate cancer. Leuprolide and goserelin-both approved to treat prostate cancer-reduce testosterone production, which, in most patients, reduces the size of the tumor. Thalidomide, a drug used for many years to treat leprosy, blocks the growth of blood vessels that may be important to disease progression. Patients 18 years or older with testosterone-dependent prostate cancer that has persisted or recurred after having had surgery, radiation therapy, or cryosurgery, but whose disease has not metastasized (spread beyond the prostate) may be eligible for this study. Candidates are screened with a medical history and physical examination, including blood tests, bone and computed tomography (CT) scans or other imaging studies. Study participants are randomly assigned to one of two treatment groups. One group receives leuprolide or goserelin followed by thalidomide; the other receives leuprolide or goserelin followed by placebo (a look-alike pill with no active ingredients). Patients in both groups receive an injection of leuprolide or goserelin once a month for 6 months. After that time they take four capsules of either thalidomide or placebo once a day and remain on the drug until their prostate-specific antigen (PSA) level returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower.(PSA is a protein secreted by the prostate gland. Monitoring changes in levels of this protein can help evaluate tumor progression). At this point the entire procedure begins again, starting with leuprolide or goserelin treatment, but the experimental drug is switched; patients originally treated with thalidomide are crossed over to placebo, and patients originally treated with placebo are crossed over to thalidomide. Patients are monitored periodically with the following tests and procedures: Medical histories and physical examinations. Blood and urine tests to monitor thalidomide and PSA levels, the response to treatment, and routine laboratory values (e.g., cell counts and kidney and liver function). Computed tomography (CT) and bone scans, and possibly other imaging tests to assess the tumor. Electromyography (EMG) and nerve conduction studies, as needed. For electromyography, a thin needle is inserted into a few muscles and the patient is asked to relax or to contract the muscles.
NCT00004635 ↗ Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer Completed Louisiana State University Health Sciences Center in New Orleans Phase 3 2000-03-01 This multi-center study will evaluate whether thalidomide can improve the effectiveness of the drugs leuprolide or goserelin in treating testosterone-dependent prostate cancer. Leuprolide and goserelin-both approved to treat prostate cancer-reduce testosterone production, which, in most patients, reduces the size of the tumor. Thalidomide, a drug used for many years to treat leprosy, blocks the growth of blood vessels that may be important to disease progression. Patients 18 years or older with testosterone-dependent prostate cancer that has persisted or recurred after having had surgery, radiation therapy, or cryosurgery, but whose disease has not metastasized (spread beyond the prostate) may be eligible for this study. Candidates are screened with a medical history and physical examination, including blood tests, bone and computed tomography (CT) scans or other imaging studies. Study participants are randomly assigned to one of two treatment groups. One group receives leuprolide or goserelin followed by thalidomide; the other receives leuprolide or goserelin followed by placebo (a look-alike pill with no active ingredients). Patients in both groups receive an injection of leuprolide or goserelin once a month for 6 months. After that time they take four capsules of either thalidomide or placebo once a day and remain on the drug until their prostate-specific antigen (PSA) level returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower.(PSA is a protein secreted by the prostate gland. Monitoring changes in levels of this protein can help evaluate tumor progression). At this point the entire procedure begins again, starting with leuprolide or goserelin treatment, but the experimental drug is switched; patients originally treated with thalidomide are crossed over to placebo, and patients originally treated with placebo are crossed over to thalidomide. Patients are monitored periodically with the following tests and procedures: Medical histories and physical examinations. Blood and urine tests to monitor thalidomide and PSA levels, the response to treatment, and routine laboratory values (e.g., cell counts and kidney and liver function). Computed tomography (CT) and bone scans, and possibly other imaging tests to assess the tumor. Electromyography (EMG) and nerve conduction studies, as needed. For electromyography, a thin needle is inserted into a few muscles and the patient is asked to relax or to contract the muscles.
NCT00004635 ↗ Thalidomide for the Treatment of Hormone-Dependent Prostate Cancer Completed United States Naval Medical Center, Portsmouth Phase 3 2000-03-01 This multi-center study will evaluate whether thalidomide can improve the effectiveness of the drugs leuprolide or goserelin in treating testosterone-dependent prostate cancer. Leuprolide and goserelin-both approved to treat prostate cancer-reduce testosterone production, which, in most patients, reduces the size of the tumor. Thalidomide, a drug used for many years to treat leprosy, blocks the growth of blood vessels that may be important to disease progression. Patients 18 years or older with testosterone-dependent prostate cancer that has persisted or recurred after having had surgery, radiation therapy, or cryosurgery, but whose disease has not metastasized (spread beyond the prostate) may be eligible for this study. Candidates are screened with a medical history and physical examination, including blood tests, bone and computed tomography (CT) scans or other imaging studies. Study participants are randomly assigned to one of two treatment groups. One group receives leuprolide or goserelin followed by thalidomide; the other receives leuprolide or goserelin followed by placebo (a look-alike pill with no active ingredients). Patients in both groups receive an injection of leuprolide or goserelin once a month for 6 months. After that time they take four capsules of either thalidomide or placebo once a day and remain on the drug until their prostate-specific antigen (PSA) level returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower.(PSA is a protein secreted by the prostate gland. Monitoring changes in levels of this protein can help evaluate tumor progression). At this point the entire procedure begins again, starting with leuprolide or goserelin treatment, but the experimental drug is switched; patients originally treated with thalidomide are crossed over to placebo, and patients originally treated with placebo are crossed over to thalidomide. Patients are monitored periodically with the following tests and procedures: Medical histories and physical examinations. Blood and urine tests to monitor thalidomide and PSA levels, the response to treatment, and routine laboratory values (e.g., cell counts and kidney and liver function). Computed tomography (CT) and bone scans, and possibly other imaging tests to assess the tumor. Electromyography (EMG) and nerve conduction studies, as needed. For electromyography, a thin needle is inserted into a few muscles and the patient is asked to relax or to contract the muscles.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Thalomid

Condition Name

Condition Name for Thalomid
Intervention Trials
Multiple Myeloma 20
Prostate Cancer 4
Stage I Multiple Myeloma 4
Stage II Multiple Myeloma 4
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Condition MeSH

Condition MeSH for Thalomid
Intervention Trials
Multiple Myeloma 29
Neoplasms, Plasma Cell 28
Prostatic Neoplasms 6
Lymphoma 5
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Clinical Trial Locations for Thalomid

Trials by Country

Trials by Country for Thalomid
Location Trials
United States 265
China 11
Canada 7
Australia 3
Belgium 2
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Trials by US State

Trials by US State for Thalomid
Location Trials
Texas 18
New York 13
Illinois 12
Arkansas 12
Pennsylvania 12
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Clinical Trial Progress for Thalomid

Clinical Trial Phase

Clinical Trial Phase for Thalomid
Clinical Trial Phase Trials
Phase 4 2
Phase 3 17
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Thalomid
Clinical Trial Phase Trials
Completed 40
Terminated 18
Active, not recruiting 7
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Clinical Trial Sponsors for Thalomid

Sponsor Name

Sponsor Name for Thalomid
Sponsor Trials
National Cancer Institute (NCI) 31
Celgene Corporation 18
M.D. Anderson Cancer Center 10
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Sponsor Type

Sponsor Type for Thalomid
Sponsor Trials
Other 75
Industry 33
NIH 32
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Thalidomide: Clinical Trials, Market Analysis, and Projections

Introduction

Thalidomide, a drug with a complex and storied history, has evolved from its initial use as a sedative to become a crucial component in the treatment of various cancers, particularly multiple myeloma and chronic lymphocytic leukemia (CLL). This article delves into the recent clinical trials, market analysis, and future projections for thalidomide.

Clinical Trials Update

Thalidomide in Chronic Lymphocytic Leukemia (CLL)

A significant clinical trial has explored the safety and efficacy of thalidomide in combination with fludarabine in patients with previously untreated CLL. This phase 1/2 study involved 13 patients who received continuous daily thalidomide (at doses of 100, 200, and 300 mg) along with standard monthly doses of fludarabine. The results were promising, with no dose-limiting toxicity reached and an overall response rate of 100%, including 55% of patients achieving complete remissions. At a median follow-up of over 15 months, none of the patients had relapsed, and the median time to disease progression had not been reached[1].

Mechanism of Action

Thalidomide's exact mechanism of action remains unclear, but it is known to have antiangiogenic and immunomodulatory effects through the modulation of cytokines such as tumor necrosis factor-alpha (TNF-α) and vascular endothelial growth factor (VEGF) in the tumor microenvironment[1].

Market Analysis

Global Thalidomide Market

The global thalidomide market is anticipated to experience significant growth from 2021 to 2028, with a projected Compound Annual Growth Rate (CAGR) of 6.80%. This growth is driven by the increasing prevalence of diseases such as multiple myeloma, erythema nodosum leprosum, and graft vs. host disease, along with rising government funding and emerging market opportunities[3].

Market Segmentation

The thalidomide market is segmented by type (50mg, 100mg, 150mg, 200mg), application (multiple myeloma, erythema nodosum leprosum, graft vs. host disease, etc.), demographic (children, adults), dosage form (capsule, tablet), route of administration (oral), and end-users (clinics, hospitals). North America dominates the market due to the presence of major pharmaceutical players and a well-developed healthcare sector[3].

Market Outlook for Multiple Myeloma

Current Market Size and Forecast

The multiple myeloma treatment market is expected to reach $37.5 billion by 2031, growing at a CAGR of 5.7%. This growth is driven by factors such as long treatment durations, prolonged survival rates, and the introduction of novel therapies. However, the market for branded multiple myeloma drugs is expected to decline post-2025 due to generic erosion of immunomodulators like thalidomide, lenalidomide, and proteasome inhibitors[5].

Regional Market Analysis

In 2017, the total market size of multiple myeloma therapies in the United States was $9,467 million, while in the EU-5 countries it was $3,139 million, and in Japan it was $1,019 million. These markets are expected to increase during the forecast period from 2017 to 2030[2].

Pipeline Development and Generic Entry

Lenalidomide and Thalidomide

Lenalidomide, a second-generation immunomodulatory drug related to thalidomide, dominates the multiple myeloma market. However, generic entry for lenalidomide is expected to begin in 2022, and in the European Union, the patent is set to expire in 2024, leading to increased generic competition. Despite this, lenalidomide is expected to maintain a strong presence in the market[2].

Challenges and Opportunities

Side Effects and Toxicities

Thalidomide is associated with several side effects, including fatigue, constipation, peripheral sensory neuropathy, and an increased risk of venous thromboembolism (VTE). These side effects can hamper market growth but also highlight the need for strategies to manage and prevent treatment-related toxicities[1][3].

Emerging Markets and R&D Activities

The growing focus on novel treatment therapies and increasing research and development activities in emerging markets present significant opportunities for the global thalidomide market. Rising healthcare expenditure and government support in regions like Asia-Pacific are expected to drive market growth[3].

Key Takeaways

  • Clinical Efficacy: Thalidomide has shown promising results in clinical trials, particularly in combination with fludarabine for CLL, with high response rates and no relapses at follow-up.
  • Market Growth: The global thalidomide market is expected to grow at a CAGR of 6.80% from 2021 to 2028, driven by increasing disease prevalence and emerging market opportunities.
  • Market Size: The multiple myeloma treatment market, where thalidomide plays a significant role, is projected to reach $37.5 billion by 2031.
  • Generic Competition: The market will face generic competition post-2025, which may impact the sales of branded thalidomide and related drugs.
  • Side Effects and Management: Managing side effects and toxicities associated with thalidomide remains a critical challenge.

FAQs

What is the current status of thalidomide in clinical trials for CLL?

Thalidomide has shown encouraging clinical efficacy and acceptable toxicity in phase 1 trials when combined with fludarabine for previously untreated CLL, with a 100% overall response rate and no relapses at follow-up[1].

How is the global thalidomide market expected to grow?

The global thalidomide market is expected to grow at a CAGR of 6.80% from 2021 to 2028, driven by increasing disease prevalence and emerging market opportunities[3].

What are the main side effects associated with thalidomide?

Common side effects include fatigue, constipation, peripheral sensory neuropathy, and an increased risk of venous thromboembolism (VTE)[1][3].

How will generic competition affect the thalidomide market?

Generic competition, particularly for lenalidomide, is expected to begin in 2022 and will increase post-2025, potentially impacting the sales of branded thalidomide and related drugs[2].

What are the emerging trends in the multiple myeloma treatment market?

Emerging trends include the introduction of novel therapies, such as bispecific antibodies and CAR-T therapy, which are expected to witness significant growth rates over the forecast period[5].

Sources

  1. Results of a phase 1 clinical trial of thalidomide in combination with fludarabine in patients with CLL. Blood, 106(10), 3348-20928.
  2. Multiple Myeloma in 8 Major Markets 2017-2030. Business Wire.
  3. Global Thalidomide Market - Industry Trends and Forecast to 2028. Data Bridge Market Research.
  4. THALOMID Product Monograph. Bristol Myers Squibb.
  5. Global Multiple Myeloma Treatment Market. iHealthcareAnalyst.

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