MicrotransplantationNCT02981199
Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
A study testing stem cell transplantation in people with Microtransplantation and Autologous Stem Cell Transplantation, run by Chen Wenming at 1 site in China.
Trial summary
Comparison of the efficacy and safety of microtransplantation and autologous transplantation in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been observed. To identify the role of microtransplantation in the treatment of multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Microtransplantation, Autologous Stem Cell Transplantation, Multiple Myeloma in Relapse
- What is being tested?
- stem cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2019
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis MM compliance with IMWG diagnostic criteria(2014)
- induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR
- KPS ≥60，ECOG≤2 4）Age 18-65，eligible for SCT 5）Heart function < II level (NYHA standard) and ejection fraction > 50% -
Who cannot join
- KPS<60
- Allergy to bortezomib,epirubicin, or drug ingredients
- Severe hepatitis and organ dysfunction: a serious infection has not been controlled; cardiac ejection fraction <50%, serum bilirubin >3mg/dl, severe abnormal results of liver function test (AST is greater than 3 times the upper limit), severe renal injury; central nervous system disorders, uncontrolled mental illness
- With more than 2 bortezomib associated with peripheral neuropathy or neuralgia patients
- Patients with active stage of the herpes zoster
- Women in pregnancy or lactation
Show all 10Show fewer
- MM with AL or EM plasma cell tumor
- The patient refused to accept the above treatment and signature
- Donor does not meet the requirements: including HIV positive, active hepatitis B, bone marrow disease, donor refused to provide hematopoietic stem cells and do not agree to sign.
- Epirubicin / other anthracyclines previously accumulated more than 240mg/m2 -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Guorong Wang, doctor, +861085231572, blunlake@163.com
Wenming Chen, doctor, +861085231581, wenming_chen@yahoo.com
About this study
Official title: A Prospective, Multi-center, Randomized Controlled Trial of Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
Comparison of the efficacy and safety of microtransplantation and autologous transplantation in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been observed. To identify the role of microtransplantation in the treatment of multiple myeloma.
Read the detailed description
NDMM patients induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR, eligible for SCT, were randomly divided into two arms. One arm receive microtransplantation, and the other accept auto-SCT. Comparison of the efficacy and safety of two arms, 2-year PFS and OS were also been observed. Clear the above program related hematopoietic recovery, remission rate, infection and recurrence rate, survival rate and the formation of micro inlay, minimal residual disease and GVHD, etc. To identify the role of microtransplantation in the treatment of multiple myeloma.
- Being tested
- stem cell transplantation
- Keywords
- microtransplantation, multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cell transplantationProcedure or surgery
conditioning with chemotherapy [VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)], then stem cell transfusion
| Study group | Role | What they receive |
|---|---|---|
| Micro-SCT | Active comparator | patients treated with microtransplantation. [VMD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; melphalan 60mg/m2 d1; dexamethasone 20mg d1,2,4,5,8,9,11,12) + low dose allogeneic stem cell transplantation]×4cycles; [PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)]×1cycle; then maintenance therapy with thalidomide 100mg/d.
microtransplantation = [VMD regimen chemotherapy+ low dose allogeneic stem cell transplantation]×4cycles Receives: Procedure: stem cell transplantation |
| Auto-SCT | Active comparator | patients treated with Auto-SCT. conditioning with Mel+Vel regimen (melphalan 200mg/m2 d-2, bortezomib 1.3mg/m2 d-6,-3,+1,+4) + autogeneic stem cell transplantation; [PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)]×4cycle; then maintenance therapy with thalidomide 100mg/d. Receives: Procedure: stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 2 years
overall survival
Measured: 2 years
Secondary outcomes (6)
rate of complete remission
Measured: 2 year
minimal residual disease
Measured: 2 year
hematopoietic recovery
Measured: 3 month
infection
Measured: 3 month
GVHD
Measured: 1 year
relapse
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrotransplantationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Wenming
- Sponsor type
- University, hospital or other
- Collaborators
- 307 Hospital of PLA
- Responsible party
- Sponsor-investigator, Chen Wenming, Beijing Chao Yang Hospital
- Investigators
- Wenming Chen, doctor, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981199
- Sponsor's protocol ID
- MM-MSCT-001
- Status last verified
- Dec 2016
- First submitted
- 30 Nov 2016
- Last updated
- 16 Dec 2016
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled Trial of Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT02981199
- Acronym / sponsor ID
- MM-MSCT-001
- Keywords
- microtransplantation, multiple myeloma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chen WenmingUniversity, hospital or other
- Collaborators
- 307 Hospital of PLA
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 5 Dec 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.
Comparison of the efficacy and safety of microtransplantation and autologous transplantation in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been observed. To identify the role of microtransplantation in the treatment of multiple myeloma.
Detailed description
NDMM patients induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR, eligible for SCT, were randomly divided into two arms. One arm receive microtransplantation, and the other accept auto-SCT. Comparison of the efficacy and safety of two arms, 2-year PFS and OS were also been observed. Clear the above program related hematopoietic recovery, remission rate, infection and recurrence rate, survival rate and the formation of micro inlay, minimal residual disease and GVHD, etc. To identify the role of microtransplantation in the treatment of multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro-SCT | Active comparator | Procedure: stem cell transplantationpatients treated with microtransplantation. [VMD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; melphalan 60mg/m2 d1; dexamethasone 20mg d1,2,4,5,8,9,11,12) + low dose allogeneic stem cell transplantation]×4cycles; [PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)]×1cycle; then maintenance therapy with thalidomide 100mg/d. microtransplantation = [VMD regimen chemotherapy+ low dose allogeneic stem cell transplantation]×4cycles |
| Auto-SCT | Active comparator | Procedure: stem cell transplantationpatients treated with Auto-SCT. conditioning with Mel+Vel regimen (melphalan 200mg/m2 d-2, bortezomib 1.3mg/m2 d-6,-3,+1,+4) + autogeneic stem cell transplantation; [PTD chemotherapy(bortezomib 1.3mg/m2 d1,4,8,11; thalidomide 100mg/d, dexamethasone 20mg d1,2,4,5,8,9,11,12)]×4cycle; then maintenance therapy with thalidomide 100mg/d. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis MM compliance with IMWG diagnostic criteria(2014)
- induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR
- KPS ≥60，ECOG≤2 4）Age 18-65，eligible for SCT 5）Heart function < II level (NYHA standard) and ejection fraction > 50% -
Key exclusion criteria (10 listed)
- KPS<60
- Allergy to bortezomib,epirubicin, or drug ingredients
- Severe hepatitis and organ dysfunction: a serious infection has not been controlled; cardiac ejection fraction <50%, serum bilirubin >3mg/dl, severe abnormal results of liver function test (AST is greater than 3 times the upper limit), severe renal injury; central nervous system disorders, uncontrolled mental illness
- With more than 2 bortezomib associated with peripheral neuropathy or neuralgia patients
- Patients with active stage of the herpes zoster
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 |
|---|---|---|
| stem cell transplantationconditioning with chemotherapy [VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)], then stem cell transfusion | Procedure or surgery | Auto-SCT, Micro-SCT |
Primary outcome
progression-free survival
Time frame: 2 years
overall survival
Time frame: 2 years
6 secondary outcomes
rate of complete remission
Time frame: 2 year
minimal residual disease
Time frame: 2 year
hematopoietic recovery
Time frame: 3 month
infection
Time frame: 3 month
GVHD
Time frame: 1 year
relapse
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 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.
Wenming Chen, 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 study testing stem cell transplantation in people with Microtransplantation and Autologous Stem Cell Transplantation, run by Chen Wenming 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 3 inclusion and 10 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 16 Dec 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.
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 Guorong Wang, doctor (+861085231572, blunlake@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 2 years). The study lists 2 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 16 Dec 2016.