Tolerability and Efficacy of Modified VCD Regimens in Previously Untreated Multiple Myeloma.
Status:
Unknown status
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
Summary
This phase 2 study will be conducted at 10 centers and enroll patients from August 2013 to
August 2017.Firstly, All patients included will provide written informed consent. Secondly,
they will be randomized equally to receive modified VCD regimen arm 1 or modified VCD regimen
arm 2. In total, 47 patients per arm (or 94 in total) are required. The treatment consists of
four 4-week cycles of induction therapy followed by intensive therapy with another five
modified VCD regimens and maintenance treatment with CP regimen. Then, patients will be
followed up for 24 months after chemotherapy. The investigators will record all the
laboratory and clinical investigations to assess response at different points of the study.
We also monitor and assess adverse events (AEs), as graded according to NCI-CTCAE Version
3.0.Response categories were based on the International Myeloma Working Group uniform
response criteria.In addition, 20 patients (10 in VCD regimen arm 1 group, 10 in VCD regimen
arm 2 group) from ten centres will be enrolled in the pharmacodynamic substudy.