TreatmentPhase 1/2NCT02971982
PCD Versus RCD for the Treatment of Patients With Waldenstrom's Macroglobulinemia
A Phase 1/2 study testing rituximab /Dexamethasone/cyclophosphamide and Velcade/Dexamethasone/cyclophosphamide in people with Treatment, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Treatment
- What is being tested?
- rituximab /Dexamethasone/cyclophosphamide and Velcade/Dexamethasone/cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2018
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recently diagnosed WM according to the second 2002 WM international working group
- Not previously treated, apart from not regularly received by Chlorambucil
- Aged from 18 to 75 years, both male and female
- Ability to give signed informed consent
- Negative pregnancy test at inclusion (if necessary)
- ECOG from 0 to 2
Who cannot join
- Known hypersensitivity to rituximab or velcade or cyclophosphamide
- Uncontrolled infection including bacteria, virus and fungus, including active HBV infection
- Organic dysfunction: Bilirubin > 1.5 x normal above, Renal failure requiring dialysis, glutamic pyruvic transaminase (ALT) and Glutamic-Oxaloacetic Aminotransferase (AST) > 2.5 x normal above
- Positive HIV serology
- Serious psychiatric item in the history
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital, Soochow University
Suzhou, Jiangsu, 215000
Fu chengcheng, Phd, 13962191404, evergirl@sina.com
About this study
Official title: Velcade/Dexamethasone/Cyclophosphamide(PCD) Versus Rituximab /Dexamethasone/Cyclophosphamide(RCD) for the Treatment of Patients With Waldenstrom's Macroglobulinemia
Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
Read the detailed description
This is an open-label, single-centre, randomised study, looking at a series of 40 patients up to the age of 75 with newly diagnosed Waldenstrom's macroglobulinemia (WM) not previously treated. Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
- Conditions
- Treatment
- Being tested
- rituximab /Dexamethasone/cyclophosphamide, Velcade/Dexamethasone/cyclophosphamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximab /Dexamethasone/cyclophosphamideDrug
rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg
Velcade/Dexamethasone/cyclophosphamideDrug
Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg
| Study group | Role | What they receive |
|---|---|---|
| rituximab /Dex/CTX | Experimental | rituximab /Dexamethasone/cyclophosphamide 6 cycles followed by rituximab (at least 2 cycles) rituximab:375mg/m2 d1 Dexamethasone:40mg d1-4 cyclophosphamide:750mg/m2,d1-28 Receives: Drug: rituximab /Dexamethasone/cyclophosphamide |
| Velcade/Dex/CTX | Experimental | Velcade/Dexamethasone/cyclophosphamide 6 cycles followed by velcade (at least 2 cycles) Velcade:1.3mg/m2 d1,d4,d8,d11 Dexamethasone:20mg d1-2,d4-5,d8-9,d11-12 cyclophosphamide:750mg/m2,d1-28 Receives: Drug: Velcade/Dexamethasone/cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigators try to compare the very good partial remission (VGPR) rate at the end of the research.
Measured: 2 years
Investigators try to compare the complete remission (CR) rates at the end of the research.
Measured: 2 years
Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research.
Measured: 2 years
Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
Measured: 2 yeas
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fu cheng cheng, Phd, Principal investigator, First Affiliated Hospital,Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971982
- Sponsor's protocol ID
- myeloma-02
- Status last verified
- Oct 2016
- First submitted
- 19 Oct 2016
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Velcade/Dexamethasone/Cyclophosphamide(PCD) Versus Rituximab /Dexamethasone/Cyclophosphamide(RCD) for the Treatment of Patients With Waldenstrom's Macroglobulinemia
- ClinicalTrials.gov ID
- NCT02971982
- Acronym / sponsor ID
- myeloma-02
- Conditions
- Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Nov 2016 (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.
Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
Detailed description
This is an open-label, single-centre, randomised study, looking at a series of 40 patients up to the age of 75 with newly diagnosed Waldenstrom's macroglobulinemia (WM) not previously treated. Patients will receive RCD or PCD combination as induction treatment followed by rituximab or velcade maintenance therapy, as the investigators try to compare the, very good partial remission (VGPR) rate, complete remission (CR) rates, Overall remission rate (MR+CR + VGPR + partial remission (PR) rate), major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rituximab /Dex/CTX | Experimental | Drug: rituximab /Dexamethasone/cyclophosphamiderituximab /Dexamethasone/cyclophosphamide 6 cycles followed by rituximab (at least 2 cycles) rituximab:375mg/m2 d1 Dexamethasone:40mg d1-4 cyclophosphamide:750mg/m2,d1-28 |
| Velcade/Dex/CTX | Experimental | Drug: Velcade/Dexamethasone/cyclophosphamideVelcade/Dexamethasone/cyclophosphamide 6 cycles followed by velcade (at least 2 cycles) Velcade:1.3mg/m2 d1,d4,d8,d11 Dexamethasone:20mg d1-2,d4-5,d8-9,d11-12 cyclophosphamide:750mg/m2,d1-28 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Recently diagnosed WM according to the second 2002 WM international working group
- Not previously treated, apart from not regularly received by Chlorambucil
- Aged from 18 to 75 years, both male and female
- Ability to give signed informed consent
- Negative pregnancy test at inclusion (if necessary)
Key exclusion criteria (5 listed)
- Known hypersensitivity to rituximab or velcade or cyclophosphamide
- Uncontrolled infection including bacteria, virus and fungus, including active HBV infection
- Organic dysfunction: Bilirubin > 1.5 x normal above, Renal failure requiring dialysis, glutamic pyruvic transaminase (ALT) and Glutamic-Oxaloacetic Aminotransferase (AST) > 2.5 x normal above
- Positive HIV serology
- Serious psychiatric item in the history
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 |
|---|---|---|
| rituximab /Dexamethasone/cyclophosphamiderituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg | Drug | rituximab /Dex/CTX |
| Velcade/Dexamethasone/cyclophosphamideVelcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg | Drug | Velcade/Dex/CTX |
Primary outcome
Investigators try to compare the very good partial remission (VGPR) rate at the end of the research.
Time frame: 2 years
Investigators try to compare the complete remission (CR) rates at the end of the research.
Time frame: 2 years
Investigators try to compare Overall remission rate (MR+CR + VGPR + partial remission (PR) rate) at the end of the research.
Time frame: 2 years
Investigators try to compare major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
Time frame: 2 yeas
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- 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.
Fu cheng cheng, Phd principal investigator
First Affiliated Hospital,Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing rituximab /Dexamethasone/cyclophosphamide and Velcade/Dexamethasone/cyclophosphamide in people with Treatment, run by The First Affiliated Hospital of Soochow University 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 6 inclusion and 5 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 23 Nov 2016. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Fu cheng cheng, PhD (86-512-67781856, evergirl@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigators try to compare the very good partial remission (VGPR) rate at the end of the research. (time frame: 2 years). The study lists 4 primary outcomes in all. 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 23 Nov 2016.