A Phase Ib trial of oral azacitidine in combination with lenalidomide and dexamethasone (Rd) for myeloma patients with relapsed and/or refractory multiple myeloma who have failed a prior lenalidomide-containing regimen

The Alfred Hospital0 sites30 target enrollmentMarch 8, 2013

Overview

No summary available.

Registry

who.int

Start Date

March 8, 2013

End Date

January 24, 2018

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

The Alfred Hospital

•1\. Age 18 years and above
•2\. Confirmed diagnosis of MM as per IMWG criteria
•3\. ECOG performance status 0\-2
•4\. Relapsed and/or refractory MM with a history of lenalidomide failure where lenalidomide failure is defined as
•a) Progressive disease while on a lenalidomide containing regimen OR b) Progressive disease within 60 days of completing a lenalidomide containing regimen OR c)Failure to achieve at least a minimal response (MR) with 4 cycles of lenalidomide containing therapy when such therapy was administered either as part of initial therapy for newly diagnosed MM or as salvage therapy for the treatment of relapsed/refractory MM.
•5\. Adequate liver and kidney function (\<2 x institutional upper limit of normal)
•6\. Platelet count \> 75 x 109/L, absolute neutrophil count \> 1\.0 x 109/L
•7\. No contraindication to the use of azacitidine, lenalidomide or dexamethasone
•8\. Patient has voluntarily agreed and has given written informed consent.
•9\. Life expectancy of \> 8 weeks

•1\. Patients with monoclonal gammopathy of uncertain significance.
•2\. Primary amyloidosis
•3\. Patients who have received prior allogeneic transplantation \< 12 months prior to entering study
•4\. Patients who have had prior allogeneic transplantation and show evidence of active graft\-versus\-host disease that requires immunosuppressive therapy
•5\. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•6\. Patients with a prior malignancy within the last 5 years (except for basal or squamous cell carcimnoma or in situ cancer of the cervix).
•7\. Pregnant or lactating women.
•8\. Known hepatitis B, Hepatitis C, HIV infection, other immunosuppressive therapy or autoimmune disease