A Phase 2, Multicenter, Single Arm Study to Evaluate the Effect of PAD Followed by Autologous Stem-cell Transplantation(ASCT) on the Concentrations of Bone Metabolites in Patients With Newly Diagnosed Multiple Myeloma(MM)
After providing written informed consent, subjects will be evaluated for eligibility during
a 14-day screening period. Eligible subjects will receive 4 cycles PAD treatment prior to
ASCT. Bisphosphonate therapy can be administered as medically indicated and according to
local practice.
After the end of the treatment phase, there will be 18 months follow-up period for every
patient with visits at 4, 6, 12 and 18 months after the end of the treatment phase. In case
the disease progresses before completing the 18 months of follow-up and once the subject
started alternative MM treatment, study assessments will stop, except for survival follow-up
which will be collected every 6 months by either a telephone call or a visit to the study
site. The follow-up for survival will continue for all subjects until the last subject has
completed follow-up. One interim analysis of efficacy and safety will be performed when all
subjects have achieved the end of treatment. Safety will be assessed by the monitoring of
adverse events, physical examination, vital signs measurements and clinical laboratory
tests.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Bone markers measurement
The following serum biochemical markers of bone remodeling are going to be measured: 1) bone formation marker : PICP, b ALP; 2) bone resorption marker: ICTP; 3) osteoclast stimulators: OPG, sRANKL;4) osteoblast inhibitor: DKK-1. All these markers are going to be measured on serum samples as previously described by ELISA methodology at baseline, on day 28 of cycles 1,4, and after 4, 6, 12 and 18 months of follow-up or until start of alternative MM treatment, if earlier.
Up to Cycle 4 with 28 days per cycle
No
Jian Hou, PhD
Principal Investigator
Shanghai Changzheng Hospital
China: Food and Drug Administration
26866138MMY2074
NCT01852799
December 2012
December 2016
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