Clinical Trial Finder

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

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  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 -

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.

Arms

Experimental: A:Allogeneic Stem Cell Transplant Group

Fludarabine+Melphalan followed by Allogeneic SCT.

Experimental: B:Autologous Stem Cell Transplant

Melphalan followed by Autologous SCT.

Experimental: C:Non-Transplant

Consolidated Chemotherapy for Patients Unable to Receive Transplantation

Interventions

Procedure: - Allogeneic Hematopoietic Stem Cell Transplantation

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.

Procedure: - Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2

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.

Drug: - Melphalan Given IV

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

Drug: - Fludarabine Injection

conditioning regimen:Days -6,-5,-4,-3 Fludarabine 30 mg/m^2/day IV

Drug: - PI and dexamethasone as maintenance therapy

Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)

Drug: - PI+IMids+Dexamethasone as Consolidated Chemotherapy

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.