a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients
Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk Multiple Myeloma
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-myeloma
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2018
CompletedFirst Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedJuly 5, 2019
July 1, 2019
2 years
June 21, 2019
July 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
overall response(ORR)
1 Year post-autograft
overall survival(OS)
1 Year post-autograft
Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
1 year post-allograft
Non-relapse Mortality (NRM)
1 year post-allograft
Number of Patients Who Had Infections
1 Year post-autograft
Study Arms (3)
A:Allogeneic Stem Cell Transplant Group
EXPERIMENTALFludarabine+Melphalan followed by Allogeneic SCT.
B:Autologous Stem Cell Transplant
EXPERIMENTALMelphalan followed by Autologous SCT.
C:Non-Transplant
EXPERIMENTALConsolidated Chemotherapy for Patients Unable to Receive Transplantation
Interventions
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.
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.
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
conditioning regimen:Days -6,-5,-4,-3 Fludarabine 30 mg/m\^2/day IV
Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)
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.
Eligibility Criteria
You may qualify if:
- 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 -
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lu G Qiu, Dr.
Institute of Hematology & Blood Diseases Hospital, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
June 21, 2019
First Posted
July 5, 2019
Study Start
January 5, 2018
Primary Completion
January 1, 2020
Study Completion
August 1, 2020
Last Updated
July 5, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share