CLINICAL TRIALS PROFILE FOR ALKERAN

All Clinical Trials for Alkeran

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002556 ↗	Combination Chemotherapy With or Without High Dose Cyclophosphamide and Recombinant Interferon Alfa-2b in Treating Patients With Previously Untreated Stage I-III Multiple Myeloma	Completed	National Cancer Institute (NCI)	Phase 3	1994-07-01	This randomized phase III clinical trial studies combination chemotherapy with high dose cyclophosphamide and recombinant interferon alfa-2b to see how well it works compared to combination chemotherapy alone in treating patients with previously untreated stage I-III multiple myeloma. Drugs used in chemotherapy, such as vincristine sulfate, carmustine, melphalan, cyclophosphamide, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Recombinant interferon alfa-2b may interfere with the growth of cancer cells. It is not yet know whether giving combination chemotherapy with or without alternating high-dose cyclophosphamide and recombinant interferon alfa-2b is more effective in treating multiple myeloma.
NCT00002594 ↗	Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors	Completed	National Cancer Institute (NCI)	Phase 2	1994-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so that they stop growing or die. bone marrow transplantation and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow transplantation and/or peripheral stem cell transplantation in treating patients who have recurrent medulloblastoma or CNS germ cell tumors.
NCT00002594 ↗	Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors	Completed	Children's Oncology Group	Phase 2	1994-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so that they stop growing or die. bone marrow transplantation and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow transplantation and/or peripheral stem cell transplantation in treating patients who have recurrent medulloblastoma or CNS germ cell tumors.
NCT00002835 ↗	Combination Chemotherapy in Treating Patients With Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	1995-10-30	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma.
NCT00002835 ↗	Combination Chemotherapy in Treating Patients With Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 3	1995-10-30	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma.
NCT00003199 ↗	Combination Chemotherapy and Peripheral Blood Stem Cell Transplant Followed By Aldesleukin and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-11-01	This phase II trial studies how well giving combination chemotherapy and peripheral blood stem cell transplant followed by aldesleukin and sargramostim works in treating patients with inflammatory stage IIIB or metastatic stage IV breast cancer. Drugs used in chemotherapy, such as busulfan, melphalan, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving aldesleukin together with sargramostim may kill more tumor cells

Clinical Trial Conditions for Alkeran

Condition Name

Condition Name for Alkeran
Intervention	Trials
Multiple Myeloma	39
Lymphoma	27
Leukemia	24
Myeloma	15

Condition MeSH

Condition MeSH for Alkeran
Intervention	Trials
Multiple Myeloma	74
Neoplasms, Plasma Cell	64
Lymphoma	48
Leukemia	41

Clinical Trial Locations for Alkeran

Trials by Country

Trials by Country for Alkeran
Location	Trials
United States	513
Canada	25
Australia	9
Italy	7
Switzerland	6

Trials by US State

Trials by US State for Alkeran
Location	Trials
Texas	54
California	31
New York	30
Massachusetts	22
Minnesota	20

Clinical Trial Progress for Alkeran

Clinical Trial Phase

Clinical Trial Phase for Alkeran
Clinical Trial Phase	Trials
Phase 3	15
Phase 2/Phase 3	5
Phase 2	86

Clinical Trial Status

Clinical Trial Status for Alkeran
Clinical Trial Phase	Trials
Completed	84
Recruiting	33
Active, not recruiting	26

Clinical Trial Sponsors for Alkeran

Sponsor Name

Sponsor Name for Alkeran
Sponsor	Trials
National Cancer Institute (NCI)	64
M.D. Anderson Cancer Center	44
Masonic Cancer Center, University of Minnesota	12

Sponsor Type

Sponsor Type for Alkeran
Sponsor	Trials
Other	216
NIH	70
Industry	43

ALKERAN (Melphalan): Clinical Trials, Market Analysis, and Projections

Introduction

ALKERAN, also known as melphalan, is a chemotherapy medication widely used in the treatment of various cancers, including multiple myeloma, ovarian cancer, melanoma, and AL amyloidosis. This article provides an update on the clinical trials, market analysis, and projections for ALKERAN.

Clinical Trials and Safety Profile

Recent Developments with Pepaxto (Melphalan Flufenamide)

While ALKERAN itself is not the focus of recent clinical trial controversies, its derivative, melphalan flufenamide (Pepaxto), has been under scrutiny. The FDA announced the withdrawal of approval for Pepaxto due to the failure of the confirmatory OCEAN trial to verify its clinical benefit and concerns over its safety and efficacy[1][4].

ALKERAN Clinical Use

ALKERAN (melphalan) has a well-established safety profile when used according to its approved indications. It is administered orally or intravenously and is known for its common side effects, which include nausea, bone marrow suppression, and other hematologic abnormalities[5].

Market Analysis

Global Market Overview

The global market for ALKERAN is part of the broader chemotherapy market, which is driven by the increasing incidence of cancer and the need for effective treatments. The market for melphalan is expected to grow, albeit modestly, due to its established use in various cancer types.

Market Segments

• By Type: ALKERAN is available in both oral and intravenous forms. The intravenous form, particularly under the brand name Evomela, is often preferred in certain clinical settings due to its bioavailability and reduced risk of gastrointestinal side effects[5].
• By Region: The market is segmented into major regions including the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan. These regions are expected to dominate the market due to higher healthcare spending and better access to cancer treatments[5].

Market Size and Growth

The market size for ALKERAN is expected to see steady growth from 2025 to 2031, driven by the increasing demand for cancer treatments and the drug's established efficacy in multiple myeloma and other cancers. The Compound Annual Growth Rate (CAGR) is anticipated to be moderate, reflecting the stability of the chemotherapy market[2].

Competitor Analysis

ALKERAN faces competition from other chemotherapy agents and newer targeted therapies. However, its long-standing presence and proven efficacy in specific cancer types ensure it remains a viable option for many patients. Key competitors include other alkylating agents and newer drugs in the pipeline for multiple myeloma and other cancers[2].

Market Projections

Forecast Period

The forecast period for the ALKERAN market extends from 2025 to 2031. During this time, the market is expected to grow due to several factors:

• Increasing Cancer Diagnoses: The rising number of cancer diagnoses globally will drive the demand for chemotherapy agents like ALKERAN[3].
• Healthcare Spending: Increased healthcare spending in developed and developing countries will improve access to cancer treatments, including ALKERAN[5].

Regional Dominance

The United States and EU5 regions are expected to dominate the market due to their advanced healthcare systems and higher spending on cancer treatments. Japan is also a significant market, driven by its aging population and high healthcare standards[5].

Emerging Trends

• Personalized Medicine: The trend towards personalized medicine may impact the market for ALKERAN, as more targeted therapies become available. However, ALKERAN's broad applicability and established safety profile will likely maintain its market presence[3].
• Combination Therapies: The use of ALKERAN in combination with other therapies, such as immunomodulatory agents and monoclonal antibodies, is expected to continue and may enhance its market position[4].

Challenges and Opportunities

Challenges

• Side Effects: ALKERAN's side effects, particularly bone marrow suppression, remain a significant challenge. Managing these side effects is crucial for maintaining patient compliance and overall treatment outcomes[5].
• Competition from Newer Therapies: The emergence of newer, targeted therapies poses a competitive threat to traditional chemotherapy agents like ALKERAN. However, its established use and cost-effectiveness may mitigate this impact[3].

Opportunities

• Expanding Indications: There is potential for ALKERAN to be used in additional cancer types or in combination with other treatments, which could expand its market share[5].
• Improving Patient Outcomes: Ongoing research into optimizing dosing regimens and reducing side effects could improve patient outcomes and enhance the drug's market position.

Key Takeaways

• Established Efficacy: ALKERAN has a well-established efficacy in treating multiple myeloma and other cancers.
• Market Growth: The market for ALKERAN is expected to grow modestly from 2025 to 2031, driven by increasing cancer diagnoses and healthcare spending.
• Competition: The drug faces competition from newer targeted therapies but remains a viable option due to its proven safety profile and cost-effectiveness.
• Emerging Trends: Trends towards personalized medicine and combination therapies may impact but are unlikely to significantly diminish ALKERAN's market presence.

FAQs

What is ALKERAN used for?

ALKERAN (melphalan) is used to treat multiple myeloma, ovarian cancer, melanoma, and AL amyloidosis.

What are the common side effects of ALKERAN?

Common side effects include nausea, bone marrow suppression, and other hematologic abnormalities.

How is ALKERAN administered?

ALKERAN can be administered orally or intravenously.

What is the market outlook for ALKERAN?

The market for ALKERAN is expected to grow modestly from 2025 to 2031, driven by increasing cancer diagnoses and healthcare spending.

Does ALKERAN face competition from newer therapies?

Yes, ALKERAN faces competition from newer targeted therapies, but its established safety profile and cost-effectiveness maintain its market presence.

What regions dominate the ALKERAN market?

The United States, EU5, and Japan are expected to dominate the market due to their advanced healthcare systems and higher spending on cancer treatments.

Sources

1. FDA: FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)[1].
2. Cognitive Market Research: Alkeran Market Report 2024 (Global Edition)[2].
3. PR Newswire: ALK Inhibitors Market: A Comprehensive Overview of Current Trends and Future Projections[3].
4. FDA: FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma[4].
5. Business Wire: Melphalan (Evomela): Sold Under the Trade Name Alkeran, a Chemotherapy Medication[5].