Clinical trial · Interventional
Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
A Prospective, Multi-center, Randomized Controlled Trial of Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
NCT02981199CI-TRIAL-00025209unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autologous Stem Cell Transplantation | — | UNRESOLVED | — |
| Microtransplantation | — | UNRESOLVED | — |
| Multiple Myeloma in Relapse | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stem cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Micro-SCT
- 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
- interventionNames
- Procedure: stem cell transplantation
- type
- ACTIVE_COMPARATOR
- label
- Auto-SCT
- 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.
- interventionNames
- Procedure: stem cell transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 -
References
Publications (0)
Data not yet available
No reference posted for this study.