A Phase 4 interventional study of Bortezomib and Dexamethasone in Multiple Myeloma, sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-04.
Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment
To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.
Multiple myeloma (MM) is a common hematological malignancy in Chinese elderly population. The application of novel drugs improved the clinical outcome and survival of MM patients,even though MM remains an incurable hematological malignancy. Bortezomib is a typical one among these novel agents, its application resulted in great success, but its adverse events and high expense restricted its widely usage. Investigators modified the dose and frequency of bortezomib administration in combination therapy: Patients in the modified group received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide，while patients in the control group received similar combination therapy except with conventional bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11.
The aim of this study is to investigate whether the modified bortezomib-based therapy may attain a similar efficacy as the conventional ones.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 80 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 173 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Diagnosis of multiple myeloma based on standard diagnosis criteria:
Exclusion Criteria:
Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide
Drug: Bortezomib · Drug: Dexamethasone · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Mitoxsnteone · Drug: Thalidomide
Patients with newly diagnosed or pre-treated MM(prior therapy not including bortezomib) received bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide
Drug: Bortezomib · Drug: Dexamethasone · Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Mitoxsnteone · Drug: Thalidomide
Also known as: velcade
disease responses to treatment
Response evaluated by changes of serum M-component(g/L) through Serum quantitative immunoglobulins and Serum immunofixation electrophoresis. (g/L)
Time frame: one year
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine