Extramedullary PlasmacytomaPhase 3NCT02336386
CDD Plus Bortezomib or CDDin Relapsed or Refractory Multiple Myeloma With Extramedullary Plasmacytoma
A Phase 3 study testing CDD and CDD Plus Bortezomib in people with Extramedullary Plasmacytoma, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and Dexamethasone（CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extramedullary Plasmacytoma
- What is being tested?
- CDD and CDD Plus Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2016
- Phase
- Phase 3
- 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
- Male or female patients from 18 to 80
- Biopsy-proven EMP with relapsed or refractory Myeloma disease. Patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy
- Disease requiring further treatment
- Measurable disease such as M protein and Objective and measurable of EMP
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
- Meet the clinical laboratories criteria as specified in the protocol
- Voluntary written consent
Who cannot join
- Female patients who are lactating, breastfeeding or pregnant
- Evidence of current uncontrolled cardiovascular conditions as specified in study protocol
- Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, which would be considered as a treatment of EMP.
- Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Ongoing or active infection, known HIV positive, active hepatitis B or C infection
- Psychiatric illness/social situations that would limit compliance with study requirements
- Known allergy to any of the study medications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yuping ZHONG
Beijing, Beijing Municipality, 100043
Yuping ZHONG, Doctor, 860105171-8999, zhongyp3352@126.com
Yuping ZHONG, Doctor
About this study
Official title: Study of Cyclophosphamide，Liposome Doxorubicin Dexamethasone（CDD) Plus Bortezomib Compared With CDD in the Relapsed or Refractory Multiple Myeloma Combined With Extramedullary Plasmacytoma Patients
The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and Dexamethasone（CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.
- Conditions
- Extramedullary Plasmacytoma
- Being tested
- CDD, CDD Plus Bortezomib
- Keywords
- Bortezomib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDDDrug
Also called Cyclophosphamide,Liposome doxorubicin and Dexamethasone
Chemotherapy
CDD Plus BortezomibDrug
Also called Chemotherapy Plus Bortezomib
Chemotherapy plus Proteasome Inhibitors
| Study group | Role | What they receive |
|---|---|---|
| CDD Plus Bortezomib | Experimental | Patients will receive Bortezomib (1.3mg/m2) Subcutaneous injection on Days 1, 4,8,11 and plus dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, Liposome doxorubicin 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity. Receives: Drug: CDD Plus Bortezomib |
| CDD | Active comparator | Dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, doxorubicin Dexamethasone 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity Receives: Drug: CDD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with overall hematologic response
Complete response, very good partial response and partial response
Measured: Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months)
Secondary outcomes (6)
Number of patients with EMP response
response rate
Measured: Assessed every 2 cyeles period is projected to be approximately 24 months
Overall survival
The median overall survival
Measured: Monthly up to 3 years
Time from diagnosis ofEMP to the date of death
Measured: Monthly up to 3 years
Progression free survival
Measured: Monthly up to 2 years
Time from date of diagnosis of EMP to the date of first documentation of disease
Measured: Monthly up to 2 years
Number of adverse events
Adverse events, serious adverse events, assessment of clinical laboratory values from the date of signing of the informed consent form through 30 days after the last dose of study drug.
Measured: Monthly up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extramedullary PlasmacytomaStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital
- Responsible party
- Principal investigator, Yuping Zhong, Beijing Chao Yang Hospital
- Investigators
- Yuping Zhong, Doctor, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336386
- Sponsor's protocol ID
- CMA-MM
- Status last verified
- Jan 2015
- First submitted
- 8 Jan 2015
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cyclophosphamide，Liposome Doxorubicin Dexamethasone（CDD) Plus Bortezomib Compared With CDD in the Relapsed or Refractory Multiple Myeloma Combined With Extramedullary Plasmacytoma Patients
- ClinicalTrials.gov ID
- NCT02336386
- Acronym / sponsor ID
- CMA-MM
- Conditions
- Extramedullary Plasmacytoma
- Keywords
- Bortezomib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Peking University People's Hospital
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Jan 2015 (estimated)
- 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.
The purpose of this study is to determine whether Cyclophosphamide, Liposome doxorubicin and Dexamethasone（CDD) Plus Bortezomib might have effective in extramedullary plasmacytoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CDD Plus Bortezomib | Experimental | Drug: CDD Plus BortezomibPatients will receive Bortezomib (1.3mg/m2) Subcutaneous injection on Days 1, 4,8,11 and plus dexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, Liposome doxorubicin 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity. |
| CDD | Active comparator | Drug: CDDDexamethasone 20 mg/day PO on Days 1-4, 9-12,Cyclophosphamide 300mg/m2 D1-4, doxorubicin Dexamethasone 40mg D4 of each 28-day cycle; Patients may continue to receive treatment until PD or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients from 18 to 80
- Biopsy-proven EMP with relapsed or refractory Myeloma disease. Patients may be proteasome inhibitor-exposed or naive, but cannot be refractory to proteasome inhibitor therapy
- Disease requiring further treatment
- Measurable disease such as M protein and Objective and measurable of EMP
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
Key exclusion criteria (7 listed)
- Female patients who are lactating, breastfeeding or pregnant
- Evidence of current uncontrolled cardiovascular conditions as specified in study protocol
- Requirement for other concomitant chemotherapy, immunotherapy, radiotherapy, which would be considered as a treatment of EMP.
- Comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
- Ongoing or active infection, known HIV positive, active hepatitis B or C infection
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 |
|---|---|---|
| CDDAlso: Cyclophosphamide,Liposome doxorubicin and DexamethasoneChemotherapy | Drug | CDD |
| CDD Plus BortezomibAlso: Chemotherapy Plus BortezomibChemotherapy plus Proteasome Inhibitors | Drug | CDD Plus Bortezomib |
Primary outcome
Number of patients with overall hematologic response
Time frame: Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months)
Complete response, very good partial response and partial response
6 secondary outcomes
Number of patients with EMP response
Time frame: Assessed every 2 cyeles period is projected to be approximately 24 months
Overall survival
Time frame: Monthly up to 3 years
Time from diagnosis ofEMP to the date of death
Time frame: Monthly up to 3 years
Progression free survival
Time frame: Monthly up to 2 years
Time from date of diagnosis of EMP to the date of first documentation of disease
Time frame: Monthly up to 2 years
Number of adverse events
Time frame: Monthly up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
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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.
Yuping Zhong, Doctor principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CDD and CDD Plus Bortezomib in people with Extramedullary Plasmacytoma, run by Beijing Chao Yang 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 7 inclusion and 7 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 13 Jan 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Yuping ZHONG, Doctor (861051718999, zhongyp3352@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with overall hematologic response (time frame: Assessed every 2 cycles (median length of the endpoint assessment period is projected to be approximately 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2015.