NCT03982771

BCD Regimen in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD)

Bortezomib, Cyclophosphamide and Dexamethasone (BCD) in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD) : a Prospective, Single-center, Single-arm, Phase-II Pilot Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To explore the effectiveness and safety of bortezomib, cyclophosphamide and dexamethasone (BCD regimen) in newly diagnosed idiopathic Multicentric Castleman's disease (iMCD) patients.

Detailed description

This will be a single center, open-labeled, single arm, phase-II pilot study. The treatment and the response evaluation phase will last from the time of enrollment up to 21 months (evaluation will be carried out every 3 months in the first 9 months and every 6 months from Month 9 to Month 21). The maintenance and follow-up phase to assess for progression of disease will last from 21 months to 45 months after enrollment (evaluation will be carried out every 12 months). The total study duration will be 4 years after the last patient starts study medication.

Conditions

• Idiopathic Multicentric Castleman's Disease

Interventions

Type	Name	Description
DRUG	Bortezomib	-Bortezomib: 1.3mg/m2 subcutaneous injection on Day 1,8,15,22 every month for 9 months; And maintained with 1.3mg/m2 subcutaneous injection every two weeks from Month 9 to 21;
DRUG	Cyclophosphamide	-Cyclophosphamide: (oral) 300mg/m2 on Day 1, 8, 15, 22 every month for 9 months;
DRUG	Dexamethason	Dexamethasone: (oral) 40mg on Day 1,8,15,22 every month for 9 months; and maintained with 20mg (oral) every two weeks from Month 9 to 21.

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-01-01
• Completion: 2023-01-01
• First posted: 2019-06-12
• Last updated: 2019-06-12

Locations

1 site across 1 country: China