Pomalidomide, Ixazomib, and Dexamethasone (PId) With or Without Intensification by Cyclophosphamide (PICd): A Phase II Study in Relapsed or Refractory Multiple Myeloma

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 measurement.