Multiple Myeloma Clinical Trial
Official title:
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)
This is a multicentre; single arm study in subjects with newly diagnosed multiple myeloma.
The primary objectives of this study is to assess the effect of bortezomib combination
therapy (PAD regimen) followed by ASCT on bone metabolites in patients with newly diagnosed
multiple myeloma, as measured by ELISA methodology as previously described analyzing the
change in biochemical bone marker compared with the baseline value: bone formation marker-
bone alkaline phosphatase(bALP) and osteoblast inhibitor- Dickkopf-1(DKK-1）.
The secondary objectives of this study are:
1. Subgroup analysis for the change from baseline in biochemical bone marker based on
whether or not Bisphosphonate was used.
2. Assessment of other bone markers parameters: bone formation marker -carboxy terminal
propeptide of type I procollagen (PICP); bone resorption markers -carboxy terminal
telopeptide region of type I collagen ( ICTP); osteoclast stimulators
-osteoprotegerin(OPG), soluble receptor activator of nuclear factor kappaB
ligand(sRANKL);
3. To observe the effect of bortezomib on bone mineral density (BMD) as measured by
repeated quantitative CT-scan;
4. The evaluation of Skeletal related events (SRE) and appearance of new bone lesions;
5. To determine progression free survival (PFS), 1 year survival, overall survival and
safety profile following treatment with PAD and ASCT as first-line therapy.
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.
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