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