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Treatment Study for Patients with Relapsed/Refractory Multiple Myeloma
The goal of the trial is to assess efficacy and safety of melflufen in combination therapy in patients with relapsed/refractory multiple myeloma who are refractory to pomalidomie and/or daratumumab and to collect data.
In order to participate you must meet the following criteria:
- Have a prior diagnosis of multiple myeloma with documented disease progression in need of treatment at time of screening.
- Have a minimum of 2 prior lines of therapy, including an IMiD and a PI, and is refractory to pomalidomide and/or daratumumab. (Refractory status includes patients who relapse while on therapy or within 60 days of last dose of pomalidomide and/or daratumumab in any line, regardless of response.)
You will be excluded from the study if any of the following criteria apply to you:
- Have 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. Examples of such conditions are: a significant history of cardiovascular disease (e.g., myocardial infarction, significant conduction system abnormalities, uncontrolled hypertension, ≥ grade 3 thromboembolic event in the last 6 months).
- Have evidence of mucosal or internal bleeding and/or is platelet transfusion refractory (i.e. platelet count fails to increase by > 10,000 cells/mm3 after a transfusion of an appropriate dose of platelets).
- Have a known active infection requiring parenteral or oral anti-infective treatment within 14 days of initiation of treatment.
This is a partial list of elgibility requirements.