A Study of Melflufen in Combination With Dexamethasone in Relapsed Refractory Multiple Myeloma Patients

Overview

This study will evaluate melflufen in combination with dexamethasone in the treatment of relapsed refractory multiple myeloma in adult patients with disease refractory to pomalidomide and/or daratumumab. 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.

SparkCures ID 850
Trial Phase Phase 2
Enrollment 78 Patients
Treatments
Trial Sponsors
  • Oncopeptides AB
NCT Identifier

NCT02963493

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Innovative Clinical Research Institute

Whittier, CA

Rush University Medical Center

Chicago, IL

Hudson Valley Cancer Center

Hawthorne, NY

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

California
Innovative Clinical Research Institute

Whittier, CA

Florida
Illinois
Rush University Medical Center

Chicago, IL

Massachusetts
Michigan
New York
Hudson Valley Cancer Center

Hawthorne, NY

Texas

Resources