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Brief Title: Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in TIE Newly Diagnosed MM Patients
Official Title: Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in Transplant Ineligible Newly Diagnosed Multiple Myeloma Patients (SABLe): An Investigator Sponsored Trial
Study ID: NCT04717700
Brief Summary: An unrandomized phase 2 study of selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed, transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up within the Nordic Multiple Myeloma Study Group
Detailed Description: An unrandomized phase 2 study evaluating selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up with in the Nordic Multiple Myeloma Study Group. The study will include 50 patients, recruited within the NMSG collaborating countries. After induction patient will be treated with continued lenalidomide-dexamethasone according to SWOG, with continuous 40mg selinexor weekly in the selinexor arm (experimental arm B).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aalborg University Hospital, Aalborg, , Denmark
Sydvestjysk Sygehus Esbjerg, Esbjerg, , Denmark
Regionshospitalet Gødstrup, Gødstrup, , Denmark
Odense University Hospital, Odense, , Denmark
North Estonia Medical Centre Foundation, Tallinn, , Estonia
Haukeland University Hospital, Bergen, , Norway
Førde Central Hospital, Førde, , Norway
Kristiansund Hospital, Kristiansund, , Norway
Oslo Universitets Hospital, Oslo, , Norway
Stavanger University Hospital, Stavanger, , Norway
St. Olavs University Hospital, Trondheim, , Norway
Name: Ida B Kristensen, MB
Affiliation: Odense University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Hanne Norseth, MD
Affiliation: Oslo University Hospital
Role: PRINCIPAL_INVESTIGATOR