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

NCT03982771 | Unknown Phase 2

• 1 other identifier: ZS-1892
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Idiopathic Multicentric Castleman's Disease

Keywords

Idiopathic Multicentric Castleman's Disease; BCD Regimen; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Overall response

  Overall response is composed by biochemical, lymph node and symptom response, is the primary outcome of this study. According to the CDCN response criteria, an overall CR (complete response) requires a complete biochemical, lymph node, and symptomatic response; and overall PR (partial response) requires nothing less than a PR across all categories, but not meeting criteria for CR; an overall SD (stable disease) requires no PD (progression disease) in any of the categories and not meeting the criteria for CR or PR; an overall PD occurs when any category has a PD.

  12 months after the last patient begins study treatment.

Secondary Outcomes (13)

• Time to initial response

  12 months after the last patient begins study treatment.

• Time to best response

  12 months after the last patient begins study treatment.

• Progression-free survival (PFS)

  12 months after the last patient begins study treatment.

• Overall survival (OS)

  12 months after the last patient begins study treatment.

• Change in PHQ-9 score

  From Day 1 of the BCD treatment until 12 months after the treatment

Study Arms (1)

BCD regimen

EXPERIMENTAL

Bortezomib, cyclophosphamide and dexamethasone (the BCD regimen) would be utilized in newly diagnosed iMCD (idiopathic Multicentric Castleman's disease) patients

Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Dexamethason

Interventions

Bortezomib DRUG

-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;

BCD regimen

Cyclophosphamide DRUG

-Cyclophosphamide: (oral) 300mg/m2 on Day 1, 8, 15, 22 every month for 9 months;

BCD regimen

Dexamethason DRUG

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.

BCD regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Demography: ≥18 years, all race/ethnic groups in China;
• Newly diagnosed and previously untreated (patients are allowed to have received oral prednisone for up to 1 week before enrollment) symptomatic iMCD patients (symptomatic disease is defined by the presence of clinical symptoms with the NCI-CTCAE grading ≥1 that are attributable to the disease, and for which treatment is indicated; iMCD diagnosis is based on the international consensus diagnostic criteria);
• Clinical laboratory values meeting these criteria at screening: absolute neutrophil count ≥ 1·0 x 109/L, Platelets ≥ 50 x 109/L, Alanine aminotransferase (ALT) within 2·5 x upper limit of normal (ULN); total bilirubin within 2·5 x ULN; estimated glomerular filtration rate (according to MDRD formula) \<15ml/min;
• Women of childbearing potential must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent, and must have a negative pregnancy test at screening period. Men must agree to use birth control measures during the study and for at least 3 months after receiving the last dose of study agent;
• Informed consent must be signed.

You may not qualify if:

• age under 18 years;
• Immunosuppressive or anti-neoplastic drugs within the last 3 months;
• serious diseases including malignancy;
• Plan to have babies within 1 year after enrollment (for women and men), or pregnancy / breast-feeding (for women);
• Known hypersensitivity to study agents;
• Active infection requiring systemic treatment;
• Other severe concurrent disease (eg. uncontrolled diabetes, symptomatic coronary heart disease) that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study;
• Unwilling or unable to provide informed consent;
• Unwilling to return for follow-up at PUMCH.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

Related Publications (1)

• Zhao H, Zhang MY, Shen KN, Feng J, Cao XX, Duan MH, Zhou DB, Zhang L, Li J. A phase 2 prospective study of bortezomib, cyclophosphamide, and dexamethasone in patients with newly diagnosed iMCD. Blood. 2023 May 25;141(21):2654-2657. doi: 10.1182/blood.2023020009. No abstract available.

  PMID: 36928290 DERIVED

MeSH Terms

Conditions

Multi-centric Castleman's Disease

Interventions

Bortezomib; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in hematology

Model Details: This will be a single center, single arm, phase-II pilot study.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: June 12, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: June 12, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)