Idiopathic Multicentric Castleman's DiseasePhase 2NCT03982771
BCD Regimen in Newly Diagnosed Idiopathic Multicentric Castleman's Disease (iMCD)
A Phase 2 study testing Bortezomib, Cyclophosphamide and Dexamethason in people with Idiopathic Multicentric Castleman's Disease, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
To explore the effectiveness and safety of bortezomib, cyclophosphamide and dexamethasone (BCD regimen) in newly diagnosed idiopathic Multicentric Castleman's disease (iMCD) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Multicentric Castleman's Disease
- What is being tested?
- Bortezomib, Cyclophosphamide and Dexamethason
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Jian Li, M.D., +86-18610852525, lijian@pumch.cn
Lu Zhang, M.D., +86-18610728815, pumczhanglu@163.com
About this study
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
To explore the effectiveness and safety of bortezomib, cyclophosphamide and dexamethasone (BCD regimen) in newly diagnosed idiopathic Multicentric Castleman's disease (iMCD) patients.
Read the 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.
- Being tested
- Bortezomib, Cyclophosphamide, Dexamethason
- Keywords
- Idiopathic Multicentric Castleman's Disease, BCD Regimen, Efficacy, Safety
- Medical subject headings
- Multi-centric Castleman's Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
-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;
CyclophosphamideDrug
-Cyclophosphamide: (oral) 300mg/m2 on Day 1, 8, 15, 22 every month for 9 months;
DexamethasonDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| BCD regimen | Experimental | Bortezomib, cyclophosphamide and dexamethasone (the BCD regimen) would be utilized in newly diagnosed iMCD (idiopathic Multicentric Castleman's disease) patients Receives: Drug: Bortezomib; Drug: Cyclophosphamide; Drug: Dexamethason |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the last patient begins study treatment.
Secondary outcomes (13)
Time to initial response
defined as the time to achieve the first PR or CR. This outcome can be further divided into time to initial overall response, time to initial symptomatic response, time to initial biochemical response, time to initial lymph node response
Measured: 12 months after the last patient begins study treatment.
Time to best response
defined as the time to achieve the best response (either PR or CR). This outcome can be further divided into time to best overall response, time to best symptomatic response, time to best biochemical response, time to best lymph node response;
Measured: 12 months after the last patient begins study treatment.
Progression-free survival (PFS)
defined as the time to disease PD
Measured: 12 months after the last patient begins study treatment.
Overall survival (OS)
defined as the time to patients' death
Measured: 12 months after the last patient begins study treatment.
Change in PHQ-9 score
PHQ-9 score (Patient Health Questionnaire scale-9) is a nine-item self-administered instrument to assess depressive symptoms which incorporates the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) classification for major depressive disorder. Each item is scored 0 - 3, which results in a range of scores between 0 and 27. PHQ-9 scores are interpreted as follows: (1) score <5, no depression; (2) score 5 - 9, mild depression; (3) score 10 - 14, moderate depression; (4) score 15 - 19, moderately severe depression; and (5) score 20 - 27,severe depression.
Measured: From Day 1 of the BCD treatment until 12 months after the treatment
Change in hemoglobin level
hemoglobin with g/L as unit of measure
Measured: From baseline until 12 months after the treatment
Change in IL-6 (interleukin-6)
IL-6 level with pg/ml as unit of measure
Measured: From baseline until 12 months after the treatment
Change in CRP
CRP (c-reactive protein) level with mg/L as unit of measure
Measured: From baseline until 12 months after the treatment
Change in ESR
ESR (eerythrocyte sedimentation rate) level with mm/h as unit of measure
Measured: From baseline until 12 months after the treatment
Change in IgG level
IgG (immunoglobin G) level with g/L as unit of measure
Measured: From baseline until 12 months after the treatment
Change in MCD-related overall symptom score
Change of MCD symptom scores. MCD symptom score (MCD disease related overall symptom score) is a 34-item score based on NCI-CTCAE (V4.0) adverse events. Each item is scored 0-5, which results in a range of scores between 0 and 170. More scores indicate more severe disease activity.
Measured: From baseline until 12 months after the treatment
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 ( ≥1 grade)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (patients with grades ≥1 would be included)
Measured: 12 months after the last patient begins study treatment.
Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 ( ≥3 grade)
Number of participants with treatment-related serious adverse events as assessed by CTCAE v4.0 (patients with grades ≥3 would be included)
Measured: 12 months after the last patient begins study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Multicentric Castleman's DiseaseStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a single center, single arm, phase-II pilot study.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982771
- Sponsor's protocol ID
- ZS-1892
- Status last verified
- Jun 2019
- First submitted
- 3 May 2019
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36928290
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03982771
- Acronym / sponsor ID
- ZS-1892
- Keywords
- Idiopathic Multicentric Castleman's Disease, BCD Regimen, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a single center, single arm, phase-II pilot study.
| Arm | Type | Receives |
|---|---|---|
| BCD regimen | Experimental | Drug: Bortezomib, Drug: Cyclophosphamide, Drug: DexamethasonBortezomib, cyclophosphamide and dexamethasone (the BCD regimen) would be utilized in newly diagnosed iMCD (idiopathic Multicentric Castleman's disease) patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | BCD regimen |
| Cyclophosphamide-Cyclophosphamide: (oral) 300mg/m2 on Day 1, 8, 15, 22 every month for 9 months; | Drug | BCD regimen |
| DexamethasonDexamethasone: (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. | Drug | BCD regimen |
Primary outcome
Overall response
Time frame: 12 months after the last patient begins study treatment.
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.
13 secondary outcomes
Time to initial response
Time frame: 12 months after the last patient begins study treatment.
Time to best response
Time frame: 12 months after the last patient begins study 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 PHQ-9 score
Time frame: From Day 1 of the BCD treatment until 12 months after the treatment
Change in hemoglobin level
Time frame: From baseline until 12 months after the treatment
Change in IL-6 (interleukin-6)
Time frame: From baseline until 12 months after the treatment
Change in CRP
Time frame: From baseline until 12 months after the 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
Change in MCD-related overall symptom score
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Derived from this study: PubMed 36928290Zhao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib, Cyclophosphamide and Dexamethason in people with Idiopathic Multicentric Castleman's Disease, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response (time frame: 12 months after the last patient begins study treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982771, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.