An ALLG Trial to compare the use of Selinexor with Lenalidomide and Lenalidomide alone for patients with newly diagnosed Multiple Myeloma undergoing Autologous stem cell transplant.

Abstract

The purpose of this study to determine whether the addition of selinexor to lenalidomide maintenance therapy post Autologous Stem Cell Transplant for multiple Myeloma patients increases the proportion of patients who are progression free 3 years post randomisation.

Who is it for?

You may be eligible for this study if you are an adult who has been newly diagnosed with Multiple Myeloma and are eligible for an Autologous Stem Cell Transplant.

Study details

Participants in this study will be randomised to receive either: Lenalidomide 10mg,orally,once a day for 21 days or Lenalidomide 10mg,orally,once a day for 21 days with Selinexor 40mg,orally, weekly

Lenalidomide may be increased to 15mg orally, once a day for 21 days from cycle 4 onwards, provided good tolerance and no lenalidomide-related greater than or equal to grade 3 adverse events.

Selinexor may be maintained at 40mg orally, weekly from cycle 2 onwards provided good tolerance and no selinexor-related greater than or equal to grade 3 adverse events Each cycle lasts 28 days,

Patients will receive treatment until disease progression.

During the trial patients will have blood tests performed and bone marrow samples taken to help determined the progress of the treatment.

It is hoped that this research will help determine whether this treatment prolongs the progression free survival for patients, and what kinds of side effects/complications may occur with this treatment.