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

• Status: Active, not recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncopeptides AB
• Collaborators: Precision For Medicine; Precision Oncology
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Melphalan

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