CLINICAL TRIALS PROFILE FOR HEMADY

All Clinical Trials for HEMADY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01415882 ↗	Ixazomib Citrate in Treating Patients With Relapsed Multiple Myeloma That Is Not Refractory to Bortezomib	Recruiting	National Cancer Institute (NCI)	Phase 2	2012-01-31	This phase II trial studies how well ixazomib citrate works in treating patients with multiple myeloma that has returned after a period of improvement (relapsed) but is not resistant to bortezomib (refractory). Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
NCT01381692 ↗	Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2011-07-20	This randomized phase I/II trial studies the side effects and the best dose of temsirolimus when given together with bortezomib, rituximab, and dexamethasone and to see how well they work compared to bortezomib, rituximab, and dexamethasone alone in treating patients with untreated or relapsed Waldenstrom macroglobulinemia or relapsed or refractory mantle cell or follicular lymphoma. Bortezomib and temsirolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Bortezomib may also stop the growth of cancer cells by blocking blood flow to the tumor. Monoclonal antibodies, such as rituximab, can block cancer growth in difference ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. 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. It is not yet known whether bortezomib, rituximab, and dexamethasone are more effective with temsirolimus in treating non-Hodgkin lymphoma.
NCT01256398 ↗	Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2010-12-14	This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.
NCT00792948 ↗	Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2009-09-01	This phase II trial is studying the side effects of giving combination chemotherapy together with or without donor stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).
NCT00644228 ↗	Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2008-04-01	This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.
NCT00408005 ↗	Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 3	2007-01-22	This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating young patients with newly diagnosed T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma. After a common induction therapy, patients were risk assigned and eligible for one or both post-induction randomizations: Escalating dose Methotrexate versus High Dose Methotrexate in Interim Maintenance therapy, No Nelarabine versus Nelarabine in Consolidation therapy. T-ALL patients are risk assigned as Low Risk, Intermediate Risk or High Risk. Low Risk patients are not eligible for the Nelarabine randomization, Patients with CNS disease at diagnosis were assgined to receive High Dose Methotrexate, patients who failed induction therapy were assigned to receive Nelarabine and High Dose Methotrexate. T-LLy patients were all assigned to escalating dose Methotrexate and were risk assigned as Standard Risk, High Risk and induction failures. Standard risk patients did not receive nelarabine, High risk T-LLy patients were randomized to No Nelarabine versus Nelarabine, and Induction failures were assigned to receive Nelarabine.
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 HEMADY

Condition Name

Condition Name for HEMADY
Intervention	Trials
Refractory Plasma Cell Myeloma	10
Recurrent Plasma Cell Myeloma	10
Plasma Cell Myeloma	6
B Acute Lymphoblastic Leukemia	5

Condition MeSH

Condition MeSH for HEMADY
Intervention	Trials
Multiple Myeloma	19
Neoplasms, Plasma Cell	19
Leukemia, Lymphoid	12
Leukemia	12

Clinical Trial Locations for HEMADY

Trials by Country

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Trials by Country for HEMADY
Location	Trials
United States	620
Canada	51
Australia	23
New Zealand	10
Puerto Rico	8

Trials by US State

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−

Trials by US State for HEMADY
Location	Trials
Minnesota	23
California	21
Georgia	18
Ohio	18
Florida	17

Clinical Trial Progress for HEMADY

Clinical Trial Phase

Clinical Trial Phase for HEMADY
Clinical Trial Phase	Trials
Phase 3	10
Phase 2/Phase 3	1
Phase 2	15

Clinical Trial Status

Clinical Trial Status for HEMADY
Clinical Trial Phase	Trials
Recruiting	18
Not yet recruiting	14
Active, not recruiting	10

Clinical Trial Sponsors for HEMADY

Sponsor Name

Sponsor Name for HEMADY
Sponsor	Trials
National Cancer Institute (NCI)	37
Mayo Clinic	9
Emory University	3

Sponsor Type

Sponsor Type for HEMADY
Sponsor	Trials
NIH	37
Other	25
Industry	3

Clinical Trials, Market Analysis, and Projections for Hemady (Dexamethasone)

Introduction to Hemady

Hemady, a formulation of dexamethasone, is a corticosteroid used in the treatment of various conditions, including multiple myeloma. Here, we will delve into the clinical trials, market analysis, and projections for Hemady, particularly in the context of its use in hematology.

Clinical Trials and Approval

Background and Approval Process

Hemady, developed by Dexcel Pharma Technologies, Ltd., was submitted for FDA approval in 2018 for use in combination with other anti-multiple myeloma products for the treatment of adults with multiple myeloma. The application did not include new clinical data but relied on the FDA's previous findings of safety and efficacy for listed drugs such as Decadron (dexamethasone), Thalomid (thalidomide), and Velcade (bortezomib)[1].

Bioequivalence Studies

The approval was supported by a bioavailability study (Study 160458) that demonstrated the bioequivalence of Hemady tablets (20 mg) to West-Ward’s Dexamethasone tablets (4 mg x 5). The study showed that the 90% confidence intervals for primary pharmacokinetic parameters (Cmax, AUC0-t, and AUC0-∞) were within bioequivalence limits of 80% to 125%[1].

Clinical Efficacy and Safety

The clinical efficacy of dexamethasone in combination with other anti-myeloma therapies is well established through published literature and previous FDA approvals for other listed drugs. The safety profile was also deemed acceptable based on the existing data for Decadron and other related drugs[1].

Market Analysis

Global Hematology Drugs Market

The global hematology drugs market, which includes treatments for blood disorders such as multiple myeloma, was valued at USD 85,606.01 million in 2021 and is projected to reach USD 165,631.48 million by 2029, growing at a CAGR of 8.60% during the forecast period of 2022-2029[2].

Market Segmentation

The market is segmented by drug class, route of administration, end-users, and distribution channels. Hospitals are the most prominent end-user segment due to the increasing number of blood disorder cases. Key players in the market include Novartis AG, GlaxoSmithKline Plc., Teva Pharmaceuticals Industries Ltd., and others[2].

Competitive Landscape

The hematology-oncology market is highly competitive, with new drugs entering the market and shifting clinical preferences. For example, the emergence of BRUKINSA® and the decline of IMBRUVICA® illustrate the dynamic nature of the market. However, corticosteroids like dexamethasone remain a cornerstone in the treatment of multiple myeloma due to their established efficacy and safety profiles[5].

Market Projections for Hemady

Market Growth

Given the growing demand for hematology drugs and the established role of dexamethasone in treating multiple myeloma, Hemady is expected to contribute significantly to the market growth. The increasing prevalence of blood disorders and the need for effective combination therapies will drive the demand for Hemady.

End-User Segment

Hospitals will remain the primary end-user segment for Hemady, given the complexity and severity of multiple myeloma, which often requires hospital-based care. Specialty clinics may also play a role, especially in follow-up and maintenance treatments[2].

Distribution Channels

Hemady will likely be distributed through hospital pharmacies and retail pharmacies, with hospital pharmacies being the dominant channel due to the nature of the treatment.

Key Takeaways

• Clinical Trials: Hemady's approval was based on bioequivalence studies and the FDA's previous findings for listed drugs.
• Market Analysis: The global hematology drugs market is growing at a CAGR of 8.60%, with hospitals being the major end-user segment.
• Competitive Landscape: The market is competitive, but dexamethasone remains a crucial component in multiple myeloma treatment.
• Market Projections: Hemady is expected to contribute to market growth driven by increasing demand for effective combination therapies in treating multiple myeloma.

FAQs

What is Hemady used for?

Hemady, a formulation of dexamethasone, is used in combination with other anti-multiple myeloma products for the treatment of adults with multiple myeloma.

How was Hemady approved by the FDA?

Hemady was approved based on bioequivalence studies and the FDA's previous findings of safety and efficacy for listed drugs such as Decadron, Thalomid, and Velcade.

What is the current market size of the global hematology drugs market?

The global hematology drugs market was valued at USD 85,606.01 million in 2021 and is expected to reach USD 165,631.48 million by 2029.

Who are the key players in the hematology drugs market?

Key players include Novartis AG, GlaxoSmithKline Plc., Teva Pharmaceuticals Industries Ltd., Sanofi, F. Hoffmann-La Roche Ltd., and others.

What is the projected CAGR for the global hematology drugs market?

The market is projected to grow at a CAGR of 8.60% during the forecast period of 2022-2029.

Sources

1. FDA Summary Review: "Summary Review - accessdata.fda.gov" - September 30, 2019.
2. Data Bridge Market Research: "Global Hematology Drugs Market Size, Scope & Challenges By 2029" - Data Bridge Market Research.
3. GlobeNewswire: "Hemophilia B Drug Market Size and Share to Grow by 2032, Assesses DelveInsight" - March 27, 2024.
4. Hogan Lovells: "New FDA clinical trials guidances promote efficient drug development, innovative designs, diversity" - September 20, 2024.
5. Komodo Health: "Drug Snapshot: Shifting Paradigms in Hematology-Oncology" - Komodo Health.