a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients
- Conditions
- Multiple MyelomaPlasma Cell LeukemiaExtramedullary PlasmacytomaLoss of Chromosome 17pt(14;16)t(4;14)T(14;20)1Q21 AmplificationComplex Karyotype
- Interventions
- Procedure: Allogeneic Hematopoietic Stem Cell TransplantationProcedure: Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2Drug: PI+IMids+Dexamethasone as Consolidated Chemotherapy
- Registration Number
- NCT04008888
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
-
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
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candidate for high-dose chemotherapy with stem cell transplantation
-
ECOG performance status score of 0,1,or2 -
- The current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance of disease, Waldenstr o m macroglobulinemia.
- during the first 5 years of the study, there were no other malignancies, including basal cell carcinoma or in situ cervical cancer.
- according to the National Cancer Institute general toxicity criteria (NCI CTC), subjects had peripheral neuropathy of grade 2 or above:
- were enrolled within 6 months before had a myocardial infarction, or New York Heart Association (NYHA) III or IV heart failure ,uncontrolled angina, uncontrolled severe ventricular arrhythmias or ECG evidence of acute ischemia or conduction system abnormalities and activity the clinical significance of pericardial disease, or cardiac amyloidosis -
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A:Allogeneic Stem Cell Transplant Group Allogeneic Hematopoietic Stem Cell Transplantation Fludarabine+Melphalan followed by Allogeneic SCT. A:Allogeneic Stem Cell Transplant Group Fludarabine Injection Fludarabine+Melphalan followed by Allogeneic SCT. A:Allogeneic Stem Cell Transplant Group PI and dexamethasone as maintenance therapy Fludarabine+Melphalan followed by Allogeneic SCT. A:Allogeneic Stem Cell Transplant Group Melphalan Given IV Fludarabine+Melphalan followed by Allogeneic SCT. B:Autologous Stem Cell Transplant Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2 Melphalan followed by Autologous SCT. B:Autologous Stem Cell Transplant PI and dexamethasone as maintenance therapy Melphalan followed by Autologous SCT. C:Non-Transplant PI and dexamethasone as maintenance therapy Consolidated Chemotherapy for Patients Unable to Receive Transplantation C:Non-Transplant PI+IMids+Dexamethasone as Consolidated Chemotherapy Consolidated Chemotherapy for Patients Unable to Receive Transplantation B:Autologous Stem Cell Transplant Melphalan Given IV Melphalan followed by Autologous SCT.
- Primary Outcome Measures
Name Time Method progression free survival(PFS) 1 Year post-autograft PFS is defined as the duration from the data of registration to either progressive disease or death, whichever comes first.
- Secondary Outcome Measures
Name Time Method Non-relapse Mortality (NRM) 1 year post-allograft Number of patients with non-relapse mortalities
overall survival(OS) 1 Year post-autograft 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.
Number of Patients Who Had Infections 1 Year post-autograft Number of patients who had infections
overall response(ORR) 1 Year post-autograft ORR is defined as the proportion of subjects who achieve PR to better rate, according to the IMWG criteria
Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease 1 year post-allograft 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.
Trial Locations
- Locations (1)
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China