NCT02559154

Modified Bortezomib-based Combination Therapy for Multiple Myeloma

An Open-Label Phase IV Study of the Efficacy of Bortezomib-based Combination Therapy the Treatment of Subjects With Multiple Myeloma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bortezomib
DRUG	Dexamethasone
DRUG	Doxorubicin
DRUG	Cyclophosphamide
DRUG	Mitoxsnteone
DRUG	Thalidomide

Timeline

• Start date: 2010-07-01
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2015-09-24
• Last updated: 2018-05-04

Locations

1 site across 1 country: China