Clinical trial NCT03982771: BCD Regimen in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD)
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Idiopathic Multicentric Castleman's Disease
Keywords: Idiopathic Multicentric Castleman's Disease
BCD Regimen
Efficacy
Safety
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This will be a single center, single arm, phase-II pilot study.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Overall response
timeFrame: 12 months after the last patient begins study treatment.
Secondary outcomes:
measure: Time to initial response
timeFrame: 12 months after the last patient begins study treatment.
measure: Time to best response
timeFrame: 12 months after the last patient begins study treatment.
measure: Progression-free survival (PFS)
timeFrame: 12 months after the last patient begins study treatment.
measure: Overall survival (OS)
timeFrame: 12 months after the last patient begins study treatment.
measure: Change in PHQ-9 score
timeFrame: From Day 1 of the BCD treatment until 12 months after the treatment
measure: Change in hemoglobin level
timeFrame: From baseline until 12 months after the treatment
measure: Change in IL-6 (interleukin-6)
timeFrame: From baseline until 12 months after the treatment
measure: Change in CRP
timeFrame: From baseline until 12 months after the treatment
measure: Change in ESR
timeFrame: From baseline until 12 months after the treatment
measure: Change in IgG level
timeFrame: From baseline until 12 months after the treatment
measure: Change in MCD-related overall symptom score
timeFrame: From baseline until 12 months after the treatment
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 ( ≥1 grade)
timeFrame: 12 months after the last patient begins study treatment.
measure: Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 ( ≥3 grade)
timeFrame: 12 months after the last patient begins study treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: