A Study of PAD Followed by Autologous Stem Cell Transplantation (ASCT) to Treat Newly Diagnosed Multiple Myeloma
Status:
Completed
Trial end date:
2017-01-01
Target enrollment:
Participant gender:
Summary
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.