Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT02963493
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02963493
Study Brief:
Protocol Section:
NCT02963493