NCT02981199

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

November 30, 2016

Last Update Submit

December 15, 2016

Conditions

MicrotransplantationAutologous Stem Cell TransplantationMultiple Myeloma in Relapse

Keywords

microtransplantationmultiple myeloma

Outcome Measures

Primary Outcomes (2)

  • progression-free survival

    2 years

  • overall survival

    2 years

Secondary Outcomes (6)

  • rate of complete remission

    2 year

  • minimal residual disease

    2 year

  • hematopoietic recovery

    3 month

  • infection

    3 month

  • GVHD

    1 year

  • +1 more secondary outcomes

Study Arms (2)

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

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.

Procedure: stem cell transplantation

Interventions

stem cell transplantationPROCEDURE

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

Auto-SCTMicro-SCT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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% -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Wenming Chen, doctor

    Beijing Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guorong Wang, doctor

CONTACT

+861085231572blunlake@163.com

Wenming Chen, doctor

CONTACT

+8685231581wenming_chen@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 5, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

December 16, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)