Back to resultsMicrotransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
Primary Purpose
Microtransplantation, Autologous Stem Cell Transplantation, Multiple Myeloma in Relapse
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Microtransplantation focused on measuring microtransplantation, multiple myeloma
Eligibility Criteria
Inclusion Criteria:
- 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% -
Exclusion Criteria:
- 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
- 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 -
Sites / Locations
- Beijing Chaoyang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Micro-SCT
Auto-SCT
Arm Description
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
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.
Outcomes
Primary Outcome Measures
progression-free survival
overall survival
Secondary Outcome Measures
rate of complete remission
minimal residual disease
hematopoietic recovery
infection
GVHD
relapse
Full Information
NCT ID
NCT02981199
First Posted
November 30, 2016
Last Updated
December 15, 2016
Sponsor
Chen Wenming
Collaborators
307 Hospital of PLA
1. Study Identification
Unique Protocol Identification Number
NCT02981199
Brief Title
Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
Official Title
A Prospective, Multi-center, Randomized Controlled Trial of Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chen Wenming
Collaborators
307 Hospital of PLA
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microtransplantation, Autologous Stem Cell Transplantation, Multiple Myeloma in Relapse
Keywords
microtransplantation, multiple myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Micro-SCT
Arm Type
Active Comparator
Arm Description
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
Arm Title
Auto-SCT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
stem cell transplantation
Intervention Description
conditioning with chemotherapy [VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)], then stem cell transfusion
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
2 years
Title
overall survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
rate of complete remission
Time Frame
2 year
Title
minimal residual disease
Time Frame
2 year
Title
hematopoietic recovery
Time Frame
3 month
Title
infection
Time Frame
3 month
Title
GVHD
Time Frame
1 year
Title
relapse
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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% -
Exclusion Criteria:
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
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guorong Wang, doctor
Phone
+861085231572
Email
blunlake@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenming Chen, doctor
Phone
+8685231581
Email
wenming_chen@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenming Chen, doctor
Organizational Affiliation
Beijing Chao Yang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guorong Wang, doctor
Phone
+861085231572
Email
blunlake@163.com
First Name & Middle Initial & Last Name & Degree
Wenming Chen, doctor
Phone
+861085231581
Email
wenming_chen@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
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