CLINICAL TRIALS PROFILE FOR DEXONE 1.5

All Clinical Trials for Dexone 1.5

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00004228 ↗	Combination Chemotx in Treating Children or Adolescents With Newly Diagnosed Stg III or Stg IV Lymphoblastic Lymphoma	Completed	Children's Oncology Group	Phase 3	2000-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known which regimen of combination chemotherapy is most effective for lymphoblastic lymphoma. PURPOSE: This randomized phase III trial is studying different regimens of combination chemotherapy to compare how well they work in treating children or adolescents with newly diagnosed stage III or stage IV lymphoblastic lymphoma.
NCT00025259 ↗	Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease	Completed	National Cancer Institute (NCI)	Phase 3	2002-09-01	This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00025259 ↗	Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease	Completed	Children's Oncology Group	Phase 3	2002-09-01	This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	National Cancer Institute (NCI)	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00075725 ↗	Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia	Completed	Children's Oncology Group	Phase 3	2003-12-29	This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00096135 ↗	Combination Chemotherapy and Radiation Therapy in Treating Patients With Acute Lymphoblastic Leukemia That Has Relapsed in the CNS or Testes	Completed	National Cancer Institute (NCI)	N/A	2004-11-01	RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. PURPOSE: This clinical trial is studying how well giving chemotherapy together with radiation therapy works in treating patients with acute lymphoblastic leukemia that has relapsed in the CNS and/or testes.

Clinical Trial Conditions for Dexone 1.5

Condition Name

Condition Name for Dexone 1.5
Intervention	Trials
Recurrent Plasma Cell Myeloma	34
Refractory Plasma Cell Myeloma	29
Acute Lymphoblastic Leukemia	19
Plasma Cell Myeloma	14

Condition MeSH

Condition MeSH for Dexone 1.5
Intervention	Trials
Multiple Myeloma	61
Neoplasms, Plasma Cell	60
Leukemia	43
Precursor Cell Lymphoblastic Leukemia-Lymphoma	40

Clinical Trial Locations for Dexone 1.5

Trials by Country

Trials by Country for Dexone 1.5
Location	Trials
Canada	140
Australia	64
New Zealand	28
Puerto Rico	15
Switzerland	9

Trials by US State

Trials by US State for Dexone 1.5
Location	Trials
Texas	64
Minnesota	61
California	50
Michigan	44
Florida	44

Clinical Trial Progress for Dexone 1.5

Clinical Trial Phase

Clinical Trial Phase for Dexone 1.5
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	26
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for Dexone 1.5
Clinical Trial Phase	Trials
Recruiting	48
Completed	31
Active, not recruiting	30

Clinical Trial Sponsors for Dexone 1.5

Sponsor Name

Sponsor Name for Dexone 1.5
Sponsor	Trials
National Cancer Institute (NCI)	126
M.D. Anderson Cancer Center	30
Mayo Clinic	24

Sponsor Type

Sponsor Type for Dexone 1.5
Sponsor	Trials
NIH	127
Other	126
Industry	35

Clinical Trials, Market Analysis, and Projections for Dexamethasone (Dexone 1.5)

Introduction

Dexamethasone, often referred to by its brand name Dexone, is a widely used corticosteroid with a broad range of applications, including the treatment of multiple myeloma. This article will delve into the current clinical trials involving dexamethasone, particularly in the context of multiple myeloma, and provide an analysis of its market position and future projections.

Clinical Trials Involving Dexamethasone

Multiple Myeloma Treatment

One of the significant clinical trials involving dexamethasone is the phase Ib trial (NCT05981209) focused on treating patients with relapsed or refractory multiple myeloma (RRMM) who have received prior CD38- and BCMA-targeted therapies. This trial combines dexamethasone with elotuzumab and CC-92480 to assess the safety, side effects, and optimal dose of CC-92480 in this patient population[1].

• Trial Design: This is a dose-escalation study followed by a dose-expansion phase. Patients receive elotuzumab intravenously, CC-92480 orally, and dexamethasone intravenously or orally in a 28-day cycle.
• Objectives: The primary objectives include determining the time to response, duration of response, very good partial response or better and complete response rates, progression-free survival (PFS) at 1 year, and overall survival (OS) at 1 year. Secondary objectives include assessing minimal residual disease negativity rates and quality of life.

Other Relevant Trials

Other clinical trials and reviews highlight the use of dexamethasone in combination with various other drugs for multiple myeloma. For example, the lenalidomide-dexamethasone (RD) regimen is often used as a base case for comparison in clinical evaluations due to its established efficacy and safety profile[3].

Market Analysis

Current Market Position

Dexamethasone is a well-established drug with a long history of use across various medical conditions, including multiple myeloma. It is available in multiple formulations, such as tablets, oral solutions, and injectable forms, which makes it versatile and widely accessible[2].

• Market Players: Several pharmaceutical companies, including Lyne, Vintage Pharms, Ecr, Sti Pharma, Wockhardt Eu Operatn, Par Pharm, and Roxane, manufacture and distribute dexamethasone products.
• Prescription Status: Dexamethasone is a prescription-only medication, indicating its significant medical importance and the need for professional oversight.

Market Trends

The market for multiple myeloma treatments is evolving rapidly, with a focus on targeted therapies and combination regimens. Dexamethasone remains a cornerstone in many of these regimens due to its anti-inflammatory and immunosuppressive properties.

• Combination Therapies: The trend towards combination therapies, such as the use of dexamethasone with elotuzumab, CC-92480, daratumumab, and lenalidomide, highlights the drug's continued relevance in modern treatment protocols[1][3].

Projections and Future Outlook

Increasing Demand

The demand for effective multiple myeloma treatments is expected to rise due to the increasing incidence of the disease and the limitations of current therapies. Dexamethasone, as a component of various treatment regimens, is likely to see sustained demand.

• Epidemiological Trends: Multiple myeloma remains the second most common hematologic malignancy in the United States, and the need for effective treatments will continue to drive the market for drugs like dexamethasone[1].

Innovations and New Combinations

Future clinical trials and research are likely to explore new combinations and dosing strategies involving dexamethasone. The ongoing phase Ib trial (NCT05981209) is an example of this trend, where dexamethasone is being combined with newer agents to improve treatment outcomes for patients with relapsed or refractory multiple myeloma.

• Personalized Medicine: There is a growing interest in personalized medicine, and dexamethasone's role in tailored treatment plans could become more defined as genetic and molecular profiling of patients becomes more prevalent.

Quality of Life and Adverse Effects

The use of dexamethasone in clinical settings also involves careful consideration of its impact on patients' quality of life and potential adverse effects.

• Quality of Life: Clinical trials, such as the one mentioned, include assessments of quality of life to ensure that the treatment regimen does not significantly compromise patients' well-being[1].
• Adverse Effects: Dexamethasone is known for its side effects, including immunosuppression, which can be particularly concerning in cancer patients. Ongoing research aims to balance efficacy with safety and minimize adverse effects[2].

Key Takeaways

• Dexamethasone remains a crucial component in multiple myeloma treatment regimens, particularly in combination therapies.
• Ongoing clinical trials, such as the phase Ib trial combining dexamethasone with elotuzumab and CC-92480, are exploring new treatment strategies.
• Market demand is expected to increase due to the rising incidence of multiple myeloma and the need for effective treatments.
• Quality of life and adverse effects are critical considerations in the use of dexamethasone in clinical settings.

FAQs

What is the primary use of dexamethasone in multiple myeloma treatment?

Dexamethasone is used as part of combination therapies to treat multiple myeloma, particularly in patients who have relapsed or are refractory to other treatments.

What are the common side effects of dexamethasone?

Common side effects include immunosuppression, increased risk of infections, and various metabolic and endocrine disturbances.

How is dexamethasone administered in clinical trials for multiple myeloma?

In clinical trials, dexamethasone is often administered intravenously or orally, depending on the specific regimen and patient needs.

What is the significance of the phase Ib trial (NCT05981209)?

This trial is significant because it tests the safety and efficacy of a new combination therapy involving dexamethasone, elotuzumab, and CC-92480 for patients with relapsed or refractory multiple myeloma.

How does dexamethasone impact the quality of life of patients with multiple myeloma?

Clinical trials assess the quality of life to ensure that the treatment regimen, including dexamethasone, does not significantly compromise patients' well-being. However, dexamethasone can have side effects that may affect quality of life.

Sources

1. CareAcross: Elotuzumab, CC-92480, and Dexamethasone for the Treatment of Relapsed or Refractory Myeloma After CD38- and BCMA-Targeted Therapies. [NCT05981209].
2. PharmaCompass: Dexason | Drug Information, Uses, Side Effects, Chemistry.
3. CDA-AMC: Optimal Pharmacotherapy for Transplant-Ineligible Multiple Myeloma.