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Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients

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ClinicalTrials.gov Identifier: NCT02981199
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : December 16, 2016
Sponsor:
Collaborator:
307 Hospital of PLA
Information provided by (Responsible Party):
Chen Wenming, Beijing Chao Yang Hospital

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
Microtransplantation Autologous Stem Cell Transplantation Multiple Myeloma in Relapse Procedure: stem cell transplantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 2 years ]
  2. overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. rate of complete remission [ Time Frame: 2 year ]
  2. minimal residual disease [ Time Frame: 2 year ]
  3. hematopoietic recovery [ Time Frame: 3 month ]
  4. infection [ Time Frame: 3 month ]
  5. GVHD [ Time Frame: 1 year ]
  6. relapse [ Time Frame: 2 year ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981199


Contacts
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Contact: Guorong Wang, doctor +861085231572 blunlake@163.com
Contact: Wenming Chen, doctor +8685231581 wenming_chen@yahoo.com

Locations
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China, Beijing
Beijing Chaoyang Hospital Recruiting
Beijing, Beijing, China, 100020
Contact: Guorong Wang, doctor    +861085231572    blunlake@163.com   
Contact: Wenming Chen, doctor    +861085231581    wenming_chen@yahoo.com   
Sponsors and Collaborators
Chen Wenming
307 Hospital of PLA
Investigators
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Principal Investigator: Wenming Chen, doctor Beijing Chao Yang Hospital

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Responsible Party: Chen Wenming, professor, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02981199     History of Changes
Other Study ID Numbers: MM-MSCT-001
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Chen Wenming, Beijing Chao Yang Hospital:
microtransplantation
multiple myeloma

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Bortezomib
Melphalan
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents