Myeloproliferative Neoplasms Clinical Trial
Official title:
Multi-Center Phase II Study With Pomalidomide in Patients With Myeloproliferative Neoplasms in Fibrotic Stage
This is a phase II, multi-center study of pomalidomide in adult patients with PMF, SMF, and
unclassifiable MPN showing at least grade 1 bone marrow fibrosis and requiring therapy. All
patients will receive per oral pomalidomide on a daily basis.
First cohort (Before Amendment No. 1 ID 1-41):
Treatment starts with a phase of pomalidomide therapy with 2 mg per day. Individual dose
reduction as outlined in the safety section is allowed. If no response was achieved (no
complete remission (CR), partial response (PR), clinical improvement (CI) and no progressive
disease according to the IWG-MRT criteria) after 3 months, prednisolone is added in a
starting dose of 30 mg per day. In the absence of progressive disease, at least 6 months of
treatment with pomalidomide is intended. In patients without disease progression after 6
months and those with response to treatment are intended to receive pomalidomide for at least
12 months. Additional antiproliferative treatment with hydroxyurea for leukocytosis (>20 x
109/l) and/or thrombocytosis (>750 x 109/l) and/or symptomatic splenomegaly in a starting
dose of 2g/day with individual dose adjustment is allowed.
Second cohort (After Amendment No. 1 ID > 41):
To evaluate the relative impact of prednisolone to the objective response rate, a
randomization has been integrated into the study concept. The addition of prednisolone is
up-front randomized for the start of prednisolone either after 3 or 6 cycles of treatment
with pomalidomide as single agent if no response occurred during this period. This results in
the following treatment arms:
Treatment Arm A) Pomalidomide 0.5 mg per day + additional prednisolone at start of cycle 4
(day 85), in case no response was achieved until end of cycle 3.
Treatment Arm B) Pomalidomide 0.5 mg per day + additional prednisolone at start of cycle 7
(day 169), if no response was achieved until end of cycle 6.
Treatment for all patients starts with pomalidomide as single agent at a dose of 0.5mg per
day. The addition of prednisolone will be initiated as randomized either at start of cycle 4
or start of cycle 7 (starting dose 30 mg per day). In the absence of progressive disease, at
least 12 cycles of treatment with pomalidomide are intended.
Additional antiproliferative treatment with hydroxyurea for leukocytosis (>20 x 109/l) and/or
thrombocytosis (>750 x 109/l) and/or symptomatic splenomegaly in a starting dose of 2g/day
with individual dose adjustment is allowed.
n/a
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