Melphalan

Generic Name: Melphalan

Brand Names: Alkeran, Evomela, Phelinun, Pepaxti

Drug Type: Small Molecule

Chemical Formula: C_₁₃H_₁₈Cl_₂N_₂O_₂

CAS Number: 148-82-3

Unique Ingredient Identifier: Q41OR9510P

Background: Melphalan is a nitrogen mustard or bischloroethylamine type alkylating agent. It was first synthesized in the early 1950s by substituting L-phenylalanine for the methyl group on nitrogen mustard. Melphalan is used in the treatment of multiple myeloma and ovarian carcinoma. It is also used for high-conditioning before hematopoietic stem cell transplant. It is also used to treat uveal melanoma with unresectable hepatic metastases.

Indication: Melphalan is indicated for use as a high-dose conditioning treatment prior to hematopoietic stem cell transplantation in patients with multiple myeloma. It is also indicated for the palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary.

Melphalan is a component of HEPZATO KIT, a liver-directed therapy indicated for the treatment of adults with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

Associated Conditions: Multiple Myeloma (MM), Unresectable Liver Metastasis, Unresectable Ovarian Cancer (Epithelial)

Associated Therapies: Conditioning regimens for allogeneic stem cell transplantation therapy

Clinical Trials

Personalized NK Cell Therapy in CBT

First Posted Date: 2016-04-05

Last Posted Date: 2024-06-10

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 100

Registration Number: NCT02727803

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Procedure: Tumor Cell Collection
Procedure: Autologous Stem Cell Transplant
Drug: Melphalan
Procedure: Leukapheresis
Biological: Myeloma vaccine
Drug: GM-CSF
Drug: Lenalidomide

First Posted Date: 2016-04-05

Last Posted Date: 2024-05-07

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 203

Registration Number: NCT02728102

Locations: 🇺🇸
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸
University of Wisconsin Hospital & Clinics, Madison, Wisconsin, United States

and more 12 locations

Phase 1 Study of Tremelimumab, Durvalumab, High-dose Chemotherapy, + Autologous Stem Cell Transplant

Phase 1

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Tremelimumab
Drug: Durvalumab
Biological: Prevnar-13
Drug: Melphalan

First Posted Date: 2016-03-23

Last Posted Date: 2022-10-12

Lead Sponsor: Ludwig Institute for Cancer Research

Target Recruit Count: 6

Registration Number: NCT02716805

Locations: 🇺🇸
Research Facility, New York, New York, United States

Allogeneic Stem Cell Transplantation for Children With CML

Phase 2

Completed

Conditions: Chronic Myeloid Leukemia

Interventions: Drug: Fludarabine
Drug: Thiotepa
Drug: Melphalan
Drug: ATG
Drug: Cyclosporine A
Drug: Mycophenolate mofetil
Biological: bone marrow or peripheral blood stem cells

First Posted Date: 2016-03-14

Last Posted Date: 2021-04-15

Lead Sponsor: St. Anna Kinderkrebsforschung

Target Recruit Count: 13

Registration Number: NCT02707393

Locations: 🇦🇹
Universitätsklinik für Kinder- und Jugendheilkunde, Graz, Austria
🇨🇿
Hospital Motol, Department of Pediatric Hematology and Oncology, BMT Unit, Praha, Czechia
🇦🇹
St. Anna Kinderspital, Wien, Austria

and more 1 locations

Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma

Phase 1

Withdrawn

Conditions: Lymphoma

Interventions: Drug: Busulfan
Drug: Caphosol
Drug: Glutamine
Drug: Pyridoxine
Drug: Belinostat
Drug: Azacitidine
Drug: Gemcitabine
Drug: Melphalan
Procedure: Stem Cell Transplant

First Posted Date: 2016-03-08

Last Posted Date: 2016-05-04

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT02701673

Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation

Phase 2

Terminated

Conditions: Plasma Cell Myeloma

Interventions: Drug: Melphalan
Procedure: Peripheral Blood Stem Cell Transplantation--CD34 HSCT
Procedure: Peripheral Blood Stem Cell Transplantation--AHSCT
Biological: T Cell-Depleted Hematopoietic Stem Cell Transplantation
Biological: Tetanus Toxoid Vaccine

First Posted Date: 2016-03-07

Last Posted Date: 2024-03-12

Lead Sponsor: University of Nebraska

Target Recruit Count: 8

Registration Number: NCT02700841

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

URMC Related Haplo-identical Donor BMT

Phase 1

Completed

Conditions: Immune Deficiencies
Solid Tumors
Myelofibrosis
Multiple Myeloma
Lymphoma
Hematological Disease

Interventions: Radiation: Total Body Irradiation 1200 cGy
Drug: Fludarabine
Drug: Pre-Stem Cell Infusion Cyclophosphamide
Drug: Melphalan
Procedure: Stem Cell Infusion
Drug: Pre-Stem Cell Infusion Mesna
Drug: Post-Stem Cell Infusion Cyclophosphamide
Drug: Busulfan
Drug: Post-Stem Cell Infusion Mesna
Drug: Thiotepa

First Posted Date: 2016-01-21

Last Posted Date: 2021-11-03

Lead Sponsor: University of Rochester

Target Recruit Count: 74

Registration Number: NCT02660281

Locations: 🇺🇸
Wilmot Cancer Institute, Rochester, New York, United States

A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors

Early Phase 1

Terminated

Conditions: Neuroepithelial Tumor
Solid Tumor
Allogeneic Hematopoietic Stem Cell Transplantation

Interventions: Procedure: Allogeneic hematopoietic stem cell transplant following thiotepa-based marrow ablative chemotherapy
Drug: Keratinocyte Growth Factor
Drug: Alemtuzumab
Drug: Thiotepa
Drug: Etoposide
Drug: Fludarabine
Drug: Melphalan
Drug: Tacrolimus
Drug: Cyclosporine A
Drug: Mycophenolate mofetil

First Posted Date: 2016-01-12

Last Posted Date: 2017-08-17

Lead Sponsor: Montefiore Medical Center

Target Recruit Count: 1

Registration Number: NCT02653196

Locations: 🇺🇸
The Children's Hospital at Montefiore, The Bronx, New York, United States

A Study of Vadastuximab Talirine Given Prior to or After Allogeneic Hematopoietic Stem Cell Transplant in AML Patients

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Fludarabine
Drug: Melphalan
Drug: vadastuximab talirine

First Posted Date: 2015-11-25

Last Posted Date: 2019-01-09

Lead Sponsor: Seagen Inc.

Target Recruit Count: 14

Registration Number: NCT02614560

Locations: 🇺🇸
Colorado Blood Cancer Institute, Denver, Colorado, United States
🇺🇸
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 8 locations

Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma

Phase 2

Recruiting

Conditions: Neuroblastoma

Interventions: Drug: Thiotepa
Drug: Cyclophosphamide
Drug: Melphalan
Drug: Etoposide
Drug: Carboplatin
Biological: Autologous Stem Cell Infusion
Biological: Granulocyte colony stimulating factor

First Posted Date: 2015-11-16

Last Posted Date: 2024-07-19

Lead Sponsor: Masonic Cancer Center, University of Minnesota

Target Recruit Count: 12

Registration Number: NCT02605421

Locations: 🇺🇸
Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, United States

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