- Active, not recruiting
NCT03151811: Phase 3- Melphalan Flufenamide (Melflufen)-Dex or Pom-dex for RRMM ref. to Len. (OCEAN)
Updated: Jun 15, 2022
OCEAN
NCT03151811: Phase 3: A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide (OCEAN)
This is a randomized, controlled, open-label, Phase 3 multicenter study which will enroll patients with RRMM following 2-4 lines of prior therapy and who are 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 will receive either melflufen+dex or pomalidomide+dex.
Sponsor
Oncopeptides AB
Multiple locations
International Study
ClinicalTrials.gov Identifier: NCT03151811
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
First Posted : May 12, 2017
Click here for details on ClinicalTrials.gov
Drug: Melflufen
Drug: Pomalidomide
Drug: Dexamethasone
Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): a randomised, head-to-head, open-label, phase 3 study
Lancet Haematol; 2022 Feb
Locations
United States, Arizona
United States, California
United States, Florida
United States, Idaho
United States, Kentucky
United States, Massachusetts
United States, Mississippi
United States, North Carolina
United States, Pennsylvania
United States, Texas
Europe
United Kingdom
Austria
Belgium
Czechia
Denmark
Estonia
France
Greece
Hungary
Italy
Lithuania
Netherlands
Norway
Poland
Romania
Spain
Asia
Israel
Korea, Republic of
Russian Federation
Taiwan