Overview of Study Design:
This is an open phase II, single-arm, multi-center study to evaluate progression free
survival in patients receiving ixazomib in combination with thalidomide and dexamethasone
(ITD) followed by an ixazomib maintenance phase of a maximum period of 12 months.
The patient population will consist of adult male and female patients with multiple myeloma
(MM) with relapsed and/or refractory disease after at least one prior treatment line.
In case of enrollment patients will receive ixazomib 4.0mg at days 1, 8, 15, thalidomide
100mg at days 1 to 28 (50mg in patients aged ≥75 years), and dexamethasone 40mg (20mg in
patients aged ≥75 years) at days 1, 8, 15 of a 28-day treatment cycle. The proposed number of
cycles is 8. Treatment will be discontinued in case of progressive disease or in case of no
response after 4 cycles (≤ SD after 4 cycles). After discontinuation of therapy an end of
treatment visit (EOT) will be performed within 14 days after the last dose of the last
combination treatment cycle.
After 8 cycles of ITD therapy, maintenance treatment with 4.0mg ixazomib (3.0mg in patients
aged ≥ 75 years at first day of maintenance phase) on days 1, 8, 15 of 28-day cycles will be
administered to patients with ≥ MR for a maximum period of 12 months. Patients who completed
less than 8 cycles of ITD treatment do not qualify for maintenance phase.
Follow-up visits will be performed in 3-monthly intervals until the last patient on ixazomib
maintenance therapy has concluded or discontinued the maintenance phase.
A safety analysis will be conducted after enrollment of the first 6 patients and completion
of at least two cycles in every patient.