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Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients

NCT ID: NCT02981199

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Microtransplantation Autologous Stem Cell Transplantation Multiple Myeloma in Relapse

Keywords

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microtransplantation multiple myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

stem cell transplantation

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

stem cell transplantation

Intervention Type PROCEDURE

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

Interventions

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stem cell transplantation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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307 Hospital of PLA

OTHER

Sponsor Role collaborator

Chen Wenming

OTHER

Sponsor Role lead

Responsible Party

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Chen Wenming

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wenming Chen, doctor

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

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Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guorong Wang, doctor

Role: CONTACT

Phone: +861085231572

Email: [email protected]

Wenming Chen, doctor

Role: CONTACT

Phone: +8685231581

Email: [email protected]

Facility Contacts

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Guorong Wang, doctor

Role: primary

Wenming Chen, doctor

Role: backup

Other Identifiers

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MM-MSCT-001

Identifier Type: -

Identifier Source: org_study_id