Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 60 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Institute of Hematology & Blood Diseases Hospital|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Lu G Qiu, Dr.|
|Principal Investigator Affiliation||Institute of Hematology & Blood Diseases Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Multiple Myeloma, Plasma Cell Leukemia, Extramedullary Plasmacytoma, Loss of Chromosome 17p, t(14;16), t(4;14), T(14;20), 1Q21 Amplification, Complex Karyotype|
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.
Experimental: A:Allogeneic Stem Cell Transplant Group
Fludarabine+Melphalan followed by Allogeneic SCT.
Experimental: B:Autologous Stem Cell Transplant
Melphalan followed by Autologous SCT.
Consolidated Chemotherapy for Patients Unable to Receive Transplantation
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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.