The study is designed as a multicenter, non-randomized, Phase II trial with one treatment
arm. A total of 82 patients of both genders and older than 18 years with relapsed/refractory
multiple myeloma are planned to be included in the study. After the first 6 patients will
have finished the first treatment cycle of the induction phase the DMC will assess safety and
tolerability of the treatment schedule and decide about the further continuation of the
The study is designed as an open-label, non-randomized, multicenter study to investigate the
clinical activity of pomalidomide administered once daily in combination with oral ixazomib
and dexamethasone (PId) until disease progression according to IMWG criteria.
Patients with clinical relapse (any one of the following: deterioration of renal function,
hypercalcemia, newly developing osteolytic lesions and/or soft tissue plasmacytomas) will go
off study and receive further treatment according to their treating physician. Patients with
isolated biochemical relapse with an increase of serum M-protein of 25% (absolute increase
in serum must be 5 g/L) and/or urine M-protein (absolute increase in urine must be 200
mg/24h) or in the difference between involved and uninvolved FLC levels (provided, the
absolute increase is > 100 mg/L) without further signs or symptoms will proceed to the
intensification phase (PICd).
The intensification phase (PICd) will last until further disease progression. In case of
significant haematological and non-haematological toxicities, dose adjustments and/or
interruption of the study drugs may be necessary.
Response assessments will be performed every four weeks by evaluation of serum and 24 hour
urine specimens. "Progressive disease" (PD) will require a consecutive confirmatory
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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