Study of Melphalan Flufenamide (Melflufen) in Combination With Daratumumab in Relapsed Refractory Multiple Myeloma

• Status: Active, not recruiting
• Trial end date: 2025-11-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, controlled, open-label, Phase 3 multicenter study which will enroll patients that have Relapsed Refractory Multiple Myeloma and are double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or have received at least 3 prior lines of therapy including an IMiD and a PI.

Patients will receive treatment of melflufen+dexamethasone+daratumumab or daratumumab until documented progressive disease, unacceptable toxicity or patient/treating physician decision. Patients in the daratumumab treatment arm will after confirmed progressive disease have the option to receive treatment with melflufen+dexamethasone+daratumumab.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oncopeptides AB
• Treatments: Daratumumab; Dexamethasone; Melphalan

Criteria

Inclusion Criteria:

• A prior diagnosis of multiple myeloma with documented disease progression after last line of therapy

• Double refractory to an immunomodulatory drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or have received at least 3 prior lines of therapy including an IMiD and a PI.

• Prior treatment with daratumumab or another anti-CD38 antibody may be allowed under certain circumstances

• Male and women of childbearing potential agrees to use contraception during the treatment period and during a specified time period after the last dose

Exclusion criteria:

• Primary refractory disease (i.e. never responded with at least Minimal Response to any prior therapy for multiple myeloma)

• Prior treatment with CD38 CAR-T cell therapy or CD38/CD3 bispecific antibodies

• Any medical condition that may interfere with safety or participation in this study

• Other malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance

• Known or suspected amyloidosis, plasma cell leukemia or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)

• Known central nervous system (CNS) or meningeal involvement of myeloma

• Prior stem cell transplant (autologous and/or allogenic) within 6 months of initiation of therapy or prior allogeneic stem cell transplantation with active graft-versus-host-disease

• Prior treatment with melflufen