Multiple Myeloma in Relapse Clinical Trial
Official title:
A Phase II Trial to Evaluate the Efficacy of Daratumumab With DCEP in Multiply Myeloma Patients With Plasmacytoma Who Fail to Achieve Complete Remission With Bortezomib Containing Induction Regimen
This trial aimed to investigate the therapeutic efficacy of daratumumnab plus chemitherapy in multiple myeloma with plasmacytoma.
Multiple myeloma with plasmacytoma is a disease with significantly short overall survival.
Cancer cells in plasmacytoma has inferior response compared to cancer cells in bone marrow in
multiple myeloma. It is revealed that genetic difference such as CCND1 overexpression and RAS
mutation exists between plasmacytoma and intramedullary plasma cell myeloma, implying
different treatment strategy should be applied to overcome poor prognosis of this distinct
disorder.
Even in the era of potent IMiDs and proteasome inhibitors, median overall survival of
multiple myeloma patients with plasmacytoma is less than 5 years. Moreover, relapse in a form
of soft tissue plasmacytoma is frequently observed after triplet combination treatment in
multiple myeloma. Hence, multiple myeloma with plasmacytoma is a disease where unmet medical
need still exists.
Biologically, plasmacytoma is characterized by high plasma cell proliferation, angiogenesis
gene profile, and adhesion molecule changes mimicking solid tumor . Responsiveness to
chemotherapy used in myeloma including IMIds5 and proteasome inhibitor6 is obtuse in
plasmacytoma. Only small fraction of young patients receiving high-dose chemotherapy followed
by autologous stem cell transplantation may overcome adverse prognostic impact of
plasmacytomas . Even it is recommended that VTD-PACE would be used as the first line
treatment for plasmacytomas.
In summary, cancer cells in plasmacytoma bear biologic characteristics of solid tumor cells
and do respond to high-dose chemotherapy. And this phenomenon is very similar to lymphoma for
the following reasons. Like lymphoma, 1) plasmacytoma express tumor antigen strongly (CD38 or
CD138), 2) they form a solid mass, and 3) respond to cytotoxic chemotherapy in a
dose-response manner.
Considering the success story of rituximab in lymphoma, we conjecture that daratumumab may
work excellently to control plasmacytoma. Hence, we propose a treatment regimen consists of
DCEP chemotherapy and daratumumab.
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