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

Phase 3TerminatedNCT04649060

Oncopeptides AB54 enrolled

Overview

This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with Relapsed-Refractory Multiple Myeloma (RRMM) who were either double refractory to an Immunomodulatory Drug (IMiD) and a Proteasome Inhibitor (PI) (regardless of the number of prior lines of therapy), or had received at least 3 prior lines of therapy including an IMiD and a PI. Patients received treatment with melflufen+dexamethasone+daratumumab or daratumumab until documented progressive disease, unacceptable toxicity, or patient/treating physician decision. Patients in the daratumumab treatment arm had the option to receive treatment with melflufen+dexamethasone+daratumumab after confirmed progressive disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Relapsed Multiple Myeloma Relapsed-Refractory Multiple Myeloma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A prior diagnosis of multiple myeloma with documented disease progression after the last line of therapy * Double refractory to an IMiD and a 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: * Achieved at least partial response (PR) and not refractory to an anti-CD38 antibody * At least 6 months since the last dose of anti-CD38 antibody * Not discontinued anti-CD38 antibody treatment due to related Grade ≥ 3 toxicity * Male and female of childbearing potential agree to use contraception during the treatment period and at least 3 months 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

Locations (26)

University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinical Hematology Clinic

Plovdiv, Bulgaria

Specialized Hospital for Active Treatment of Hematological Diseases, Clinical Hematology Clinic

Sofia, Bulgaria

University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology

Brno, Czechia

University Hospital Hradec Kralove, 4th Internal Clinic of Hematology

Kralovice, Czechia

University Hospital Ostrava, Clinic of Hematooncology

Ostrava-Poruba, Czechia

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Time from the date of randomization to the date of first documentation of confirmed progressive disease (PD) or death due to any cause, whichever occurred first.