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The clinical trial was conducted in a cohort of young, high-risk myeloma patients who were designed to receive a combination of high-dose chemotherapy with allogeneic or autologous hematopoietic stem cell transplantation. The objective was to assess the progression free survival (PFS), overall survival (OS),and overall response rate (ORR) of the overall treatment.
50 cases of HR-NDMM patients were divided into two groups nonrandomizedly. TE group received hematopoietic stem cell transplantation after induction therapy. Allo-sct for the young patients with suitable donors, Asct for the others. TNE group received consolidation therapy after induction therapy. All patients received PI-based maintenance therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A:Allogeneic Stem Cell Transplant Group | Experimental | Fludarabine+Melphalan followed by Allogeneic SCT. |
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| B:Autologous Stem Cell Transplant | Experimental | Melphalan followed by Autologous SCT. |
|
| C:Non-Transplant | Experimental | Consolidated Chemotherapy for Patients Unable to Receive Transplantation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | Allogeneic Stem Cell Transplant: Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with GCSF mobilization and infused fresh to the recipients. |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival(PFS) | PFS is defined as the duration from the data of registration to either progressive disease or death, whichever comes first. | 1 Year post-autograft |
| Measure | Description | Time Frame |
|---|---|---|
| overall response(ORR) | ORR is defined as the proportion of subjects who achieve PR to better rate, according to the IMWG criteria | 1 Year post-autograft |
| overall survival(OS) | OS is defined as the duration from the data of registration to death.If the subject is alive, the data will be censored as being alive; the vital status is unknown as last known. |
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Inclusion Criteria:
Clinical diagnosis of high-risk multiple myeloma
In addition, patients must meet at least one of the following criteria I-IX (I-VIII at time of diagnosis or pre-autograft):
I.Complex karyotype
II.Fluorescent in situ hybridization (FISH) translocation 4:14 or 14:16,
III.FISH translocation 1q21,
IV.FISH deletion 17p,
V.R-ISS III stage,
VI.Two or more high-risk cytogenetic abnormalities exist
VII.Plasma cell leukemia
VIII.Extramedullary plasmacytoma
IX.Recurrent or non-responsive (less than partial remission [PR]) MM after at least 4 cycles of PI/IMids-based chemotherapy
candidate for high-dose chemotherapy with stem cell transplantation
ECOG performance status score of 0,1,or2 -
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WEI W SUI, Dr. | Contact | 86-022-23909171 | suiweiwei@ihcams.ac.cn | |
| GANG AN, Dr. | Contact | 86-022-23909171 | angang@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lu G Qiu, Dr. | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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| Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2 | Procedure | Autologous hematopoietic stem cell transplantation :Stem cell mobilization with granulocyte colony-stimulating factor (GCSF) at a dose of 10 μg/kg/day followed collecting CD34+ peripheral blood stem cells . Day 0 Infusion of autologous stem cells. Patients during 3-6 months after the 1st SCT will undergo a 2nd SCT. Patients who had not enough PBSC will undergo a 1st SCT. |
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| Melphalan Given IV | Drug | conditioning regimen: autologous ARM: Day -2 Melphalan 200 mg/m^2/day IV over 30 minutes. allogeneic ARM: Day -4, Day -3 Melphalan 70 mg/m^2/day IV over 30 minutes |
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| Fludarabine Injection | Drug | conditioning regimen:Days -6,-5,-4,-3 Fludarabine 30 mg/m^2/day IV |
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| PI and dexamethasone as maintenance therapy | Drug | Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID) |
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| PI+IMids+Dexamethasone as Consolidated Chemotherapy | Drug | Oral lenalidomide at the starting dose of 25mg on days 1-21 every 28 days or days 1-14 every 21 days. Dexamethasone at 20mg twice weekly on days 1,2,4,5,8,9,11&12 of each 21-day. |
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| 1 Year post-autograft |
| Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease | aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999). GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death cGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD. | 1 year post-allograft |
| Non-relapse Mortality (NRM) | Number of patients with non-relapse mortalities | 1 year post-allograft |
| Number of Patients Who Had Infections | Number of patients who had infections | 1 Year post-autograft |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D007952 | Leukemia, Plasma Cell |
| C538045 | Chromosome 17 deletion |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007938 | Leukemia |
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| ID | Term |
|---|---|
| D008558 | Melphalan |
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D003907 | Dexamethasone |
| D008283 | Maintenance |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D005159 | Health Care Facilities Workforce and Services |
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