Trial | NCT04649060  Report issue

Title

Study of Melphalan Flufenamide (Melflufen) in Combination With Daratumumab in Relapsed Refractory Multiple Myeloma
A Randomized, Controlled, Open-Label Phase 3 Study of Melflufen in Combination With Daratumumab Compared With Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    54
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.
Study Started
Dec 07
2020
Primary Completion
Feb 07
2022
Study Completion
Feb 07
2022
Last Update
Mar 04
2022

Drug Melphalan Flufenamide

30 mg intravenous (i.v.) infusion

  • Other names: Melflufen

Drug Dexamethasone

40 mg weekly (if ≥75 years 20 mg weekly). Oral tablets

  • Other names: Dex

Drug Daratumumab

1800 mg subcutaneous injection

  • Other names: Darzalex

Study Treatment Arm A (melflufen+dexamethasone+daratumumab) Experimental

Treatment will be given in cycles and may be given in an outpatient treatment setting. Each cycle is 28 days. Melflufen 30 mg i.v. infusion at Day 1 of each cycle Dexamethasone 40 mg p.o. weekly (if ≥75 years 20 mg weekly). Daratumumab 1800 mg s.c. Cycle 1 and 2: Day 1, 8, 15 and 22. Cycle 3 to 6: Day 1 and 15. Cycle 7+: Day 1.

Study Treatment Arm B (daratumumab) Active Comparator

Treatment will be given in cycles and may be given in an outpatient treatment setting. Each cycle is 28 days. • Daratumumab 1800 mg s.c. Cycle 1 and 2: Day 1, 8, 15 and 22. Cycle 3 to 6: Day 1 and 15. Cycle 7+: Day 1.

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
No Results Posted