Spots Global Cancer Trial Database for A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Official Title: A Single Arm, Open-Label, Phase 2 Study of Melflufen in Combination With Dexamethasone in Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Pomalidomide and/or an Anti-CD38 Monoclonal Antibody
Study ID: NCT02963493
Conditions
Study Description
Brief Summary: This study will evaluate melflufen in combination with dexamethasone in adult patients with relapsed or refractory multiple myeloma in whose disease is refractory to pomalidomide and/or an anti-CD38 monoclonal antibody. All patients in the study will be treated with melflufen on Day 1 and dexamethasone on Days 1, 8, 15 and 22 of each 28-day cycle.
Detailed Description: Melphalan flufenamide (melflufen) is a peptide-drug conjugate that rapidly delivers an alkylating payload into tumor cells. Peptidases are expressed in several cancers, including solid tumors and hematologic malignancies. Melphalan flufenamide is rapidly taken up by myeloma cells due to its high lipophilicity. Once inside the myeloma cell, the activity of melphalan flufenamide is determined by its immediate cleavage by peptidases into hydrophilic alkylator payloads that are entrapped. Melphalan flufenamide is 50-fold more potent than melphalan in myeloma cells in vitro due to increased intracellular alkylator concentration. It rapidly induces irreversible DNA damage leading to apoptosis of myeloma cells. Melphalan flufenamide displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, in vitro. Melphalan flufenamide also has demonstrated inhibition of angiogenesis and DNA damage with a lack of functional DNA repair in preclinical studies.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Innovative Clinical Research Institute (ICRI), Whittier, California, United States
University of Florida, Gainesville, Florida, United States
RUSH, Chicago, Illinois, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Center, Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Hudson Valley Hematology Oncology, Poughkeepsie, New York, United States
UPMC Hillman Cancer Insitute, Pittsburgh, Pennsylvania, United States
Baylor, Dallas, Texas, United States
CHU de Nantes, Nantes, , France
CHU de Poitiers, Poitiers, , France
Universita di Bolognia, Bologna, , Italy
Turin Hospital Myeloma Unit, Turin, , Italy
Hospital Clinic i Provincial de Barcelona, Barcelona, , Spain
Institut Català d'Oncología (ICO) Badalona, Barcelona, , Spain
Hospital Universitario de La Princesa, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Clínica Universidad de Navarra, Pamplona, , Spain
Complejo Hospitalario de Salamanca, Salamanca, , Spain
Hospital Universitario Doctor Peset, Valencia, , Spain
Contact Details
Name: Johan Harmenberg, MD, PhD
Affiliation: Oncopeptides AB
Role: STUDY_CHAIR
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