Spots Global Cancer Trial Database for Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma
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Trial Identification
Brief Title: Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma
Official Title: 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
Study ID: NCT04649060
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
General University Hospital in Prague, 1st Internal Clinic - Clinic of Hematology, Prague, , Czechia
JSC K. Eristavi National Center of Experimental and Clinical Surgery, Tbilisi, , Georgia
Malkhaz Katsiashvili Multiprofile EMC LTD, Tbilisi, , Georgia
St. Marien-Hospital Siegen gem. GmbH, Clinic for Hematology, Medical Oncology and Palliative Medicine, Siegen, , Germany
Alexandra General Hospital, Therapeutic Clinic, Athens, , Greece
General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma, Athens, , Greece
Oslo University Hospital, Ulleval University Hospital, Oslo Myeloma Center, Oslo, , Norway
Independent Public Healthcare Facility Municipal Hospitals, Teaching Department of Hematology And Prevention of Neoplastic Diseases, Chorzów, , Poland
University Clinical Center, Teaching Department of Hematology and Transplantology, Gdańsk, , Poland
Independent Public Healthcare Facility University Hospital in Krakow, Teaching Unit of the Hematology Department, Kraków, , Poland
Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz, Lodz, , Poland
St. John of Dukla Oncology Center of Lublin Region, Department of Hematology and Bone Marrow Transplantation, Lublin, , Poland
Leningrad Regional Clinical Hospital, Saint Petersburg, , Russian Federation
V.D. Seredavin Samara Regional Clinical Hospital, Samara, , Russian Federation
Clinical Center of Serbia, Belgrade, , Serbia
Hospital Clinic of Barcelona, Department of Hematology, Barcelona, , Spain
Cherkasy Regional Oncology Dispensary, Regional Treatment and Diagnostic Hematology Center, Cherkasy, , Ukraine
Chernihiv Medical Center of Modern Oncology, Hematology Department, Chernihiv, , Ukraine
City Clinical Hospital No. 4 City Hematology Center, Dnipro, , Ukraine
Kyiv City Clinical Hospital No. 9, Hematology Department No. 1, Kyiv, , Ukraine
National Institute of Cancer, Research Department of Hemoblastosis Chemotherapy and Adjuvant Treatment Methods, Department of Oncohematology with Adjuvant Treatment Methods Group, Kyiv, , Ukraine
Contact Details
Name: Maria-Victorìa Mateos, MD, PhD
Affiliation: Complejo Hospitalario de Salamanca
Role: PRINCIPAL_INVESTIGATOR
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