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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03982771
• Date of registration: 03/05/2019
• Prospective Registration: No
• Primary sponsor: Peking Union Medical College Hospital
• Public title: BCD Regimen in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD)
• Scientific title: Bortezomib, Cyclophosphamide and Dexamethasone (BCD) in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD) : a Prospective, Single-center, Single-arm, Phase-II Pilot Trial
• Date of first enrolment: January 1, 2019
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03982771
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Jian Li, M.D.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Demography: =18 years, all race/ethnic groups in China;

2. 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);

3. 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;

4. 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;

5. Informed consent must be signed.

Exclusion Criteria:

1. age under 18 years;

2. Immunosuppressive or anti-neoplastic drugs within the last 3 months;

3. serious diseases including malignancy;

4. Plan to have babies within 1 year after enrollment (for women and men), or pregnancy /
breast-feeding (for women);

5. Known hypersensitivity to study agents;

6. Active infection requiring systemic treatment;

7. 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;

8. Unwilling or unable to provide informed consent;

9. Unwilling to return for follow-up at PUMCH.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Multicentric Castleman's Disease

Intervention(s)

Drug: Bortezomib

Drug: Cyclophosphamide

Drug: Dexamethason

Primary Outcome(s)

Overall response [Time Frame: 12 months after the last patient begins study treatment.]

Secondary Outcome(s)

Time to best response [Time Frame: 12 months after the last patient begins study treatment.]

Change in hemoglobin level [Time Frame: From baseline until 12 months after the treatment]

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 ( =1 grade) [Time Frame: 12 months after the last patient begins study treatment.]

Change in IL-6 (interleukin-6) [Time Frame: From baseline until 12 months after the treatment]

Progression-free survival (PFS) [Time Frame: 12 months after the last patient begins study treatment.]

Overall survival (OS) [Time Frame: 12 months after the last patient begins study treatment.]

Change in ESR [Time Frame: From baseline until 12 months after the treatment]

Change in IgG level [Time Frame: From baseline until 12 months after the treatment]

Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 ( =3 grade) [Time Frame: 12 months after the last patient begins study treatment]

Change in PHQ-9 score [Time Frame: From Day 1 of the BCD treatment until 12 months after the treatment]

Time to initial response [Time Frame: 12 months after the last patient begins study treatment.]

Change in CRP [Time Frame: From baseline until 12 months after the treatment]

Change in MCD-related overall symptom score [Time Frame: From baseline until 12 months after the treatment]

Secondary ID(s)

ZS-1892

Source(s) of Monetary Support

Please refer to primary and secondary sponsors