Phase II Multicenter, Open-label, Single Arm Clinical Study of Pomalidomide and dexamethasonE and Cyclophosphamide
Status:
Completed
Trial end date:
2017-08-17
Target enrollment:
Participant gender:
Summary
Highest treatment efficacy in patients with refractory myeloma may be achieved with regimens
combining novel agents and alkylating agents. However, in applying this approach the patients
are at substantial risks of a critical myelosuppression. Pomalidomide demonstrates
significant activity in combination with Dexamethasone in relapsed or refractory multiple
myeloma. This trial is an attempt to further improve the efficacy of
Pomalidomide/Dexamethasone as well as to balance efficacy and toxicity. Integration of
Cyclophosphamide in the treatment in case of suboptimal response or first evidence of
progressive disease has the aim to significantly increase duration of treatment that should
have a positive impact on PFS. It is furthermore an attempt to optimize the potential of
Pomalidomide in the antimyeloma efficacy. Based on the recent findings, that myeloma is a
disease with a wide clonal heterogeneity, combination treatment in case of suboptimal myeloma
control might lead to a more effective suppression especially of aggressive subclones and
might reduce early resistance. In addition, with the goal of keeping the individual patient
as long as possible under an effective IMiD treatment, the potential of the drug might be
optimized according to the current view of maintenance treatment resulting ideally in an
outgrowth of indolent clones in the bone marrow niche.