Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma (LIGHTHOUSE)
Relapsed Multiple Myeloma, Relapsed-Refractory Multiple Myeloma
About this trial
This is an interventional treatment trial for Relapsed Multiple Myeloma
Eligibility 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
Sites / Locations
- University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Clinical Hematology Clinic
- Specialized Hospital for Active Treatment of Hematological Diseases, Clinical Hematology Clinic
- University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
- University Hospital Hradec Kralove, 4th Internal Clinic of Hematology
- University Hospital Ostrava, Clinic of Hematooncology
- General University Hospital in Prague, 1st Internal Clinic - Clinic of Hematology
- JSC K. Eristavi National Center of Experimental and Clinical Surgery
- Malkhaz Katsiashvili Multiprofile EMC LTD
- St. Marien-Hospital Siegen gem. GmbH, Clinic for Hematology, Medical Oncology and Palliative Medicine
- Alexandra General Hospital, Therapeutic Clinic
- General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma
- Oslo University Hospital, Ulleval University Hospital, Oslo Myeloma Center
- Independent Public Healthcare Facility Municipal Hospitals, Teaching Department of Hematology And Prevention of Neoplastic Diseases
- University Clinical Center, Teaching Department of Hematology and Transplantology
- Independent Public Healthcare Facility University Hospital in Krakow, Teaching Unit of the Hematology Department
- Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz
- St. John of Dukla Oncology Center of Lublin Region, Department of Hematology and Bone Marrow Transplantation
- Leningrad Regional Clinical Hospital
- V.D. Seredavin Samara Regional Clinical Hospital
- Clinical Center of Serbia
- Hospital Clinic of Barcelona, Department of Hematology
- Cherkasy Regional Oncology Dispensary, Regional Treatment and Diagnostic Hematology Center
- Chernihiv Medical Center of Modern Oncology, Hematology Department
- City Clinical Hospital No. 4 City Hematology Center
- Kyiv City Clinical Hospital No. 9, Hematology Department No. 1
- National Institute of Cancer, Research Department of Hemoblastosis Chemotherapy and Adjuvant Treatment Methods, Department of Oncohematology with Adjuvant Treatment Methods Group
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A (melflufen+dexamethasone+daratumumab)
Arm B (daratumumab)
Treatment was given in 28-day cycles in an outpatient treatment setting. Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years) Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7