Multiple Myeloma Clinical Trial
Official title:
Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk Multiple Myeloma
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | August 1, 2020 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. 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 2. candidate for high-dose chemotherapy with stem cell transplantation 3. ECOG performance status score of 0,1,or2 - Exclusion Criteria: 1. The current diagnosis of smoldering multiple myeloma, monoclonal gammopathy of undetermined significance of disease, Waldenstr o m macroglobulinemia. 2. during the first 5 years of the study, there were no other malignancies, including basal cell carcinoma or in situ cervical cancer. 3. according to the National Cancer Institute general toxicity criteria (NCI CTC), subjects had peripheral neuropathy of grade 2 or above: 4. 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 - |
Country | Name | City | State |
---|---|---|---|
China | Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Institute of Hematology & Blood Diseases Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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. | 1 Year post-autograft | |
Secondary | 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 | |
Secondary | Non-relapse Mortality (NRM) | Number of patients with non-relapse mortalities | 1 year post-allograft | |
Secondary | Number of Patients Who Had Infections | Number of patients who had infections | 1 Year post-autograft |
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