SAKK 39/16 OptiPOM – Alternierende Einnahme von Pomalidomid (jeden 2. Tag) bei Patienten mit refraktärem Multiplem Myelom. Eine multizentrische, einarmige Phase II Studie.

Drug: Pomalidomide;Drug: Dexamethasone

Key inclusion criteria:

- Patient was diagnosed with multiple myeloma based on standard IMWG criteria

- Prior treatment with = 2 treatment lines of anti-myeloma therapy

- Patients must have been exposed to both lenalidomide and bortezomib

- Measurable disease for myeloma defined as one of the following: serum M-protein = 5
g/L; urine M-protein = 0.2 g/24 hours

- Refractory or relapsed and refractory disease defined as documented disease
progression during or within 60 days of completing their last myeloma therapy.

- Adequate hematological and hepatic function

- A negative pregnancy test before inclusion into the trial is required for all women
with child-bearing potential

Key exclusion criteria:

- History of hematologic or primary solid tumor malignancy, unless in remission for at
least 3 years from registration, with the exception of pT1-2 prostate cancer Gleason
score =6, adequately treated, cervical carcinoma in situ or localized non-melanoma
skin cancer.

- Polyneuropathy grade > 2

- Patients who received any of the following within the last 14 days of initiation of
trial treatment:

- Plasmapheresis

- Major surgery (kyphoplasty is not considered major surgery)

- Radiation therapy

- Use of any anti-myeloma drug therapy

- Known or clinically suspected myeloma manifestations in the central nervous system

- Severe or uncontrolled cardiovascular disease