a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients
Multiple Myeloma, Plasma Cell Leukemia, Extramedullary Plasmacytoma
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
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:
- 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 -
Sites / Locations
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
A:Allogeneic Stem Cell Transplant Group
B:Autologous Stem Cell Transplant
C:Non-Transplant
Fludarabine+Melphalan followed by Allogeneic SCT.
Melphalan followed by Autologous SCT.
Consolidated Chemotherapy for Patients Unable to Receive Transplantation