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Last Updated: February 16, 2025

CLINICAL TRIALS PROFILE FOR EVOMELA


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All Clinical Trials for Evomela

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004088 ↗ Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma Completed National Cancer Institute (NCI) Phase 2 1999-04-13 RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies, such as interferon alfa, use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma. PURPOSE: This phase II trial is studying combination chemotherapy, peripheral stem cell transplantation, biological therapy, pamidronate, and thalidomide to see how well they work in treating patients with stage I, stage II, or stage III multiple myeloma.
NCT00004088 ↗ Combination Chemo, Peripheral Stem Cell Transplant, Biological Therapy, Pamidronate and Thalidomide for Multiple Myeloma Completed City of Hope Medical Center Phase 2 1999-04-13 RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies, such as interferon alfa, use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Pamidronate may help to reduce the side effects of treatment for multiple myeloma. PURPOSE: This phase II trial is studying combination chemotherapy, peripheral stem cell transplantation, biological therapy, pamidronate, and thalidomide to see how well they work in treating patients with stage I, stage II, or stage III multiple myeloma.
NCT00777881 ↗ Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma Completed Columbia University Phase 4 2012-09-01 The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Evomela

Condition Name

Condition Name for Evomela
Intervention Trials
Multiple Myeloma 7
Myelodysplastic Syndrome 3
Leukemia 3
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Condition MeSH

Condition MeSH for Evomela
Intervention Trials
Multiple Myeloma 11
Neoplasms, Plasma Cell 10
Leukemia, Myeloid, Acute 3
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Clinical Trial Locations for Evomela

Trials by Country

Trials by Country for Evomela
Location Trials
United States 82
Canada 5
Puerto Rico 1
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Trials by US State

Trials by US State for Evomela
Location Trials
Ohio 5
New York 5
Texas 5
California 4
Wisconsin 3
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Clinical Trial Progress for Evomela

Clinical Trial Phase

Clinical Trial Phase for Evomela
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 11
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Clinical Trial Status

Clinical Trial Status for Evomela
Clinical Trial Phase Trials
Recruiting 9
Completed 8
Active, not recruiting 1
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Clinical Trial Sponsors for Evomela

Sponsor Name

Sponsor Name for Evomela
Sponsor Trials
National Cancer Institute (NCI) 9
Spectrum Pharmaceuticals, Inc 4
M.D. Anderson Cancer Center 3
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Sponsor Type

Sponsor Type for Evomela
Sponsor Trials
Other 21
Industry 11
NIH 9
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Evomela: Clinical Trials, Market Analysis, and Projections

Introduction

Evomela, a propylene glycol-free melphalan hydrochloride for injection, has been a significant player in the treatment of multiple myeloma, particularly in the context of autologous stem cell transplantation (ASCT). Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Pivotal Clinical Study

In a pivotal Phase IIb clinical study, Evomela was evaluated for its efficacy and safety as a myeloablative conditioning regimen in patients with multiple myeloma undergoing ASCT. This open-label, single-arm, nonrandomized US clinical study enrolled 61 patients who received 200 mg/m² of IV melphalan as two doses of Evomela (100 mg/m² each) on days -3 and -2, followed by ASCT on Day 0[1][3].

Key Findings

  • Efficacy: The study demonstrated an overall response rate of 95% at follow-up (Day +90 to Day +100), with all patients achieving myeloablation and successful engraftment of neutrophils and platelets[1][3].
  • Safety: While the drug showed an acceptable safety profile, common adverse events included gastrointestinal toxicity such as nausea, vomiting, mucositis, and diarrhea. Grade 3/4 mucositis was observed in 13% of patients[1][3].

Phase IV Study in China

A prospective, multicenter, open-label Phase IV study conducted in China from July 2020 to March 2021 further validated the efficacy and safety of Evomela. This study involved 67 multiple myeloma patients who received the same dosing regimen. The results showed a median time to myeloablation of 5 days and successful engraftment of both neutrophils and platelets in all patients. The overall response rate was 92.3%, with no treatment-related mortality and manageable adverse events[4].

Market Analysis

Current Market Scenario

Evomela has been approved in several major markets, including the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. It has also been approved in China as a standard conditioning drug for ASCT in multiple myeloma patients[2][4].

Market Forecast

The market forecast for Evomela is promising, driven by the increasing demand for effective conditioning regimens in ASCT. The "EVOMELA - Emerging Insight and Market Forecast - 2030" report provides a detailed analysis of the market, including forecasted sales data from 2020 to 2030. The report highlights that the market for AL Amyloidosis, where Evomela is also being investigated, is expected to expand due to extensive research and incremental healthcare spending[2].

Competitive Landscape

Evomela faces competition from other emerging therapies for AL Amyloidosis and multiple myeloma. However, its unique formulation, which offers better solubility and stability compared to propylene glycol-based melphalan, positions it favorably in the market. The report also notes that the launch of late-stage emerging therapies will significantly impact the market, but Evomela's established efficacy and safety profile are expected to maintain its market presence[2].

Market Projections

Sales Forecast

The forecasted sales data indicate a steady growth trajectory for Evomela. The detailed market assessment in seven major markets suggests that the drug will continue to be a significant player in the conditioning regimen market for ASCT in multiple myeloma patients. The report provides in-depth analysis of the forecasted sales, which will support decision-making processes for therapeutic portfolios[2].

Regulatory Milestones

Evomela has achieved several regulatory milestones, including approvals in key markets. The ongoing research and development activities, including clinical trials and pharmacokinetic studies, further solidify its position. The drug's approval in China as a standard conditioning drug for ASCT in multiple myeloma patients is a significant milestone[4].

SWOT Analysis

A SWOT analysis of Evomela highlights its strengths, such as its proven efficacy and safety profile, better solubility and stability, and regulatory approvals. However, it also notes potential weaknesses, including the high incidence of gastrointestinal toxicity and the presence of other emerging therapies. Opportunities include the expanding market for AL Amyloidosis and the potential for use in other indications. Threats include market competition and the need for continuous monitoring of adverse events[2].

Key Takeaways

  • Clinical Efficacy: Evomela has demonstrated high efficacy as a myeloablative conditioning regimen in multiple myeloma patients undergoing ASCT, with overall response rates of 95% and 92.3% in US and Chinese studies, respectively.
  • Safety Profile: While Evomela has an acceptable safety profile, it is associated with significant gastrointestinal toxicity and other adverse events.
  • Market Forecast: The drug is expected to see steady growth in sales, driven by its approvals in major markets and its unique formulation advantages.
  • Competitive Landscape: Evomela faces competition from emerging therapies but maintains a strong market position due to its established efficacy and safety.

FAQs

What is Evomela used for?

Evomela is used as a myeloablative conditioning regimen for patients with multiple myeloma undergoing autologous stem cell transplantation (ASCT).

What are the common adverse events associated with Evomela?

Common adverse events include gastrointestinal toxicity such as nausea, vomiting, mucositis, and diarrhea, as well as other nonhematologic events like fatigue, stomatitis, and electrolyte imbalances.

How does Evomela compare to other melphalan formulations?

Evomela offers better solubility and stability compared to propylene glycol-based melphalan formulations, making it more convenient and potentially less toxic.

What are the regulatory milestones achieved by Evomela?

Evomela has been approved in the United States, EU5, Japan, and China as a standard conditioning drug for ASCT in multiple myeloma patients.

What is the market forecast for Evomela?

The market forecast indicates steady growth in sales from 2020 to 2030, driven by its approvals and unique formulation advantages.

References

  1. EVOMELA Efficacy and Safety - EVOMELA® (melphalan) for injection. Evomela.com.
  2. Melphalan (Evomela): Sold Under the Trade Name Alkeran, a Chemotherapy Medication - Global Emerging Insight and Market Forecast to 2030. ResearchAndMarkets.com.
  3. Study Design - EVOMELA.com - EVOMELA® (melphalan) for injection. Evomela.com.
  4. A Phase IV, Multicenter, Open-Label, Safety, and Efficacy Study of EVOMELA. ASH Publications.

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