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

  • End date
    Jan 1, 2023
  • participants needed
  • sponsor
    Peking Union Medical College Hospital
Updated on 23 January 2021


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


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.

Condition Idiopathic Multicentric Castleman's Disease
Treatment cyclophosphamide, Bortezomib, dexamethason
Clinical Study IdentifierNCT03982771
SponsorPeking Union Medical College Hospital
Last Modified on23 January 2021


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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Idiopathic Multicentric Castleman's Disease?
Do you have any of these conditions: Do you have Idiopathic Multicentric Castleman's Disease??
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 10 x 109/L, Platelets 50 x 109/L, Alanine aminotransferase (ALT) within 25 x upper limit of normal (ULN); total bilirubin within 25 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

Exclusion Criteria

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
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