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Brief Title: A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide
Official Title: A Randomized, Controlled, Open-label, Phase 3 Study of Melflufen/Dexamethasone Compared With Pomalidomide/Dexamethasone for Patients With Relapsed Refractory Multiple Myeloma Who Are Refractory to Lenalidomide
Study ID: NCT03151811
Brief Summary: This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with RRMM following 2-4 lines of prior therapy and who were refractory to lenalidomide in the last line of therapy as demonstrated by disease progression on or within 60 days of completion of the last dose of lenalidomide. Patients received either melflufen+dex or pomalidomide+dex.
Detailed Description: This was a randomized, controlled, open-label, Phase 3 multicenter study which enrolled patients with RRMM following 2-4 lines of prior therapy and who were refractory to lenalidomide in the last line of therapy as demonstrated by disease progression on or within 60 days of completion of the last dose of lenalidomide. Patients were randomized to either one of two arms: Arm A: Melphalan flufenamide (Melflufen) 40 mg on Day 1 and dexamethasone 40 mg on Days 1, 8, 15 and 22 of each 28-day cycle. Arm B: Pomalidomide 4 mg daily on Days 1 to 21 and dexamethasone 40 mg on Days 1, 8, 15 and 22 of each 28-day cycle. Patients ≥ 75 years of age received a reduced dose of dexamethasone of 20 mg on Days 1, 8, 15 and 22 for both Arm A and Arm B. Patients were to receive treatment until such time as there was documented disease progression, unacceptable toxicity, or the patient/treating physician determined it was not in the patient's best interest to continue. Dose modifications and delays in therapy may have been implemented based on patient tolerability as detailed in the protocol. In the event of a cycle delay, unrelated to dexamethasone toxicity, it was recommended to continue dexamethasone weekly.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
US17, Tucson, Arizona, United States
US01, Fresno, California, United States
US11, Gainesville, Florida, United States
US12, Orange City, Florida, United States
US-19, Plantation, Florida, United States
US16, Boise, Idaho, United States
US-24, Louisville, Kentucky, United States
US13, Boston, Massachusetts, United States
US-27, Hattiesburg, Mississippi, United States
US-21, Salisbury, North Carolina, United States
US-30, Winston-Salem, North Carolina, United States
US06, Philadelphia, Pennsylvania, United States
US15, Fort Sam Houston, Texas, United States
US-18, Temple, Texas, United States
AT-02, Linz, , Austria
AT-01, Vienna, , Austria
BE-05, Edegem, , Belgium
BE-03, Liège, , Belgium
BE-02, Roeselare, , Belgium
CZ-05, Brno, , Czechia
CZ-03, Hradec Králové, , Czechia
CZ-04, Olomouc, , Czechia
CZ-01, Ostrava, , Czechia
Cz-02, Cz-06, Praha, , Czechia
DK01, Vejle, , Denmark
EE-01, Tallinn, , Estonia
EE-02, Tartu, , Estonia
FR04, Brest, , France
FR-11, Cholet, , France
FR01, Le Mans, , France
FR05, Limoges, , France
FR-07, Lyon, , France
FR06, Lyon, , France
FR03, Mulhouse, , France
FR-09, Nice, , France
FR-08, Poitiers, , France
FR-10, Périgueux, , France
Gr02, Gr03, Athens, , Greece
GR04, Pátra, , Greece
GR01, Thessaloníki, , Greece
Hu02, Hu03, Hu04, Budapest, , Hungary
HU01, Debrecen, , Hungary
HU-06, Kaposvár, , Hungary
HU-05, Pécs, , Hungary
IL03, Jerusalem, , Israel
IL01, Nahariya, , Israel
IL05, Rehovot, , Israel
IL02, Safed, , Israel
IL04, Tel Aviv, , Israel
IL06, Tel Aviv, , Israel
IT07, Bergamo, , Italy
IT02, Bologna, , Italy
IT08, Brescia, , Italy
It03, It09, Milano, , Italy
IT06, Modena, , Italy
IT04, Piacenza, , Italy
IT05, Terni, , Italy
IT01, Torino, , Italy
KR-06, Busan, , Korea, Republic of
KR-05, Daegu, , Korea, Republic of
KR-04, Hwasun, , Korea, Republic of
Kr-01, Kr-02, Kr-03, Seul, , Korea, Republic of
LT-02, Kaunas, , Lithuania
LT-01, Vilnius, , Lithuania
NL01, Rotterdam, , Netherlands
NO01, Oslo, , Norway
NO-02, Ålesund, , Norway
PL03, Białystok, , Poland
PL02, Chorzów, , Poland
PL05, Lublin, , Poland
PL-08, Olsztyn, , Poland
PL07, Poznań, , Poland
PL04, Rzeszów, , Poland
PL-09, Toruń, , Poland
PL06, Łódź, , Poland
RO-02, Braşov, , Romania
RO-01, Bucharest, , Romania
RU-05, Ekaterinburg, , Russian Federation
RU-04, Izhevsk, , Russian Federation
Ru-11, Ru-14, Krasnoyarsk, , Russian Federation
RU-03, Moscow, , Russian Federation
RU-09, Nizhny Novgorod, , Russian Federation
RU-10, Novosibirsk, , Russian Federation
RU-06, Petrozavodsk, , Russian Federation
Ru-01, Ru-02, Ru-08, Ru-12, Ru-14, Saint Petersburg, , Russian Federation
RU-07, Samara, , Russian Federation
RU-13, Syktyvkar, , Russian Federation
ES11, Badalona, , Spain
Es02, Es13, Es14, Barcelona, , Spain
Es01, Es04, Es09, Madrid, , Spain
ES-15, Málaga, , Spain
Es07, Es12, Pamplona, , Spain
ES10, Salamanca, , Spain
ES03, Santa Cruz de Tenerife, , Spain
ES08, Sevilla, , Spain
Es05, Es06, Valencia, , Spain
TW-02, Chiayi City, , Taiwan
Tw-04, Tw-07, Kaohsiung, , Taiwan
TW-03, Taichung, , Taiwan
TW-05, Tainan, , Taiwan
Tw-01, Tw-06, Taipei, , Taiwan
GB03, Liverpool, , United Kingdom
GB01, Manchester, , United Kingdom
GB02, Milton Keynes, , United Kingdom
GB04, Southampton, , United Kingdom
Name: Pieter Sonneveld, Prof.
Affiliation: Erasmus Medical Center
Role: PRINCIPAL_INVESTIGATOR