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Spots Global Cancer Trial Database for A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Pieter Sonneveld, Prof.

Affiliation: Erasmus Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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