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Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients

Sponsor
Chen Wenming (Other)
Overall Status
Unknown status
CT.gov ID
NCT02981199
Collaborator
307 Hospital of PLA (Other)
80
Enrollment
1
Location
2
Arms
47
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: stem cell transplantation
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Multi-center, Randomized Controlled Trial of Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
Study Start Date :
Jan 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Micro-SCT

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

Procedure: stem cell transplantation
conditioning with chemotherapy [VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)], then stem cell transfusion
Active Comparator: Auto-SCT

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.

Procedure: stem cell transplantation
conditioning with chemotherapy [VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)], then stem cell transfusion

Outcome Measures

Primary Outcome Measures

  1. progression-free survival [2 years]

  2. overall survival [2 years]

Secondary Outcome Measures

  1. rate of complete remission [2 year]

  2. minimal residual disease [2 year]

  3. hematopoietic recovery [3 month]

  4. infection [3 month]

  5. GVHD [1 year]

  6. relapse [2 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Diagnosis MM compliance with IMWG diagnostic criteria(2014)

  2. induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR

  3. KPS ≥60，ECOG≤2 4）Age 18-65，eligible for SCT 5）Heart function < II level (NYHA standard) and ejection fraction > 50% -

Exclusion Criteria:

  1. KPS<60

  2. Allergy to bortezomib,epirubicin, or drug ingredients

  3. 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

  4. With more than 2 bortezomib associated with peripheral neuropathy or neuralgia patients

  5. Patients with active stage of the herpes zoster

  6. Women in pregnancy or lactation

  7. MM with AL or EM plasma cell tumor

  8. The patient refused to accept the above treatment and signature

  9. 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.

  10. Epirubicin / other anthracyclines previously accumulated more than 240mg/m2 -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Chaoyang Hospital Beijing Beijing China 100020

Sponsors and Collaborators

  • Chen Wenming
  • 307 Hospital of PLA

Investigators

  • Principal Investigator: Wenming Chen, doctor, Beijing Chao Yang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chen Wenming, professor, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier:
NCT02981199
Other Study ID Numbers:
  • MM-MSCT-001
First Posted:
Dec 5, 2016
Last Update Posted:
Dec 16, 2016
Last Verified:
Dec 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Chen Wenming, professor, Beijing Chao Yang Hospital
microtransplantation
multiple myeloma
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study Results

No Results Posted as of Dec 16, 2016