A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT02963493

Run by

Oncopeptides AB

People needed

157

Starts

2016-12-28

Expected to finish

2021-11-16

Last updated by the study team

2022-11-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, age 18 years or older
• A prior diagnosis of multiple myeloma with documented disease progression
• Measurable disease based on either of a) serum monoclonal protein by protein electrophoresis (SPEP), b) monoclonal protein in the urine on 24-hour urine electrophoresis (UPEP), and/or c) serum immunoglobulin free light chain combined with abnormal serum immunoglobulin kappa to lambda free light chain ratio
• A minimum of 2 prior lines of therapy including an IMiD and a PI and is refractory to pomalidomide and/or daratumumab
• Life expectancy of ≥ 6 months
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Female of child bearing potential (FCBP) and non-vasectomized male agree to practice appropriate methods of birth control
• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
• 12-lead ECG with QTc interval within defined limit
• Acceptable laboratory results during screening and prior to first study drug administration of the following parameters: absolute neutrophil count (ANC), platelet count, hemoglobin, total bilirubin, aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT), renal function based on estimated creatinine clearance
• Must have, or accept to have, an acceptable central catheter for infusion of melflufen

You may not qualify if…

• Evidence of mucosal or internal bleeding and/or is platelet transfusion refractory
• Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient or would adversely affect his/her participating in this study
• Known active infection requiring parenteral or oral anti-infective treatment within defined period
• Primary refractory disease
• Other malignancy diagnosed or requiring treatment within the defined period with specific exceptions
• Pregnant or breast-feeding females
• Serious psychiatric illness, active alcoholism, or drug addiction that may hinder or confuse compliance or follow-up evaluation
• Known HIV or active hepatitis B or C viral infection
• Concurrent symptomatic amyloidosis or plasma cell leukemia
• POEMS syndrome [plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes]
• Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within defined values prior to start of study treatment
• Residual side effects to previous therapy over specific grade prior to initiation of therapy
• Prior autologous or allogeneic stem cell transplant within defined period of initiation of therapy
• Prior allogeneic stem cell transplant with active graft-versus-host- disease (GVHD).
• Prior major surgical procedure or radiation therapy within specified period of the first dose of study treatment (with defined exception).
• Known intolerance to steroid therapy

Where it is running

• 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

Full record on ClinicalTrials.gov

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