- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04008888
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: WEI W SUI, Dr.
- Phone Number: 86-022-23909171
- Email: suiweiwei@ihcams.ac.cn
Study Contact Backup
- Name: GANG AN, Dr.
- Phone Number: 86-022-23909171
- Email: angang@ihcams.ac.cn
Study Locations
-
-
Tianjin
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Tianjin, Tianjin, China, 300020
- Recruiting
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
-
Contact:
- WEI W SUI, Master
- Phone Number: 86-022-23909171
- Email: suiweiwei@ihcams.ac.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A:Allogeneic Stem Cell Transplant Group
Fludarabine+Melphalan followed by Allogeneic SCT.
|
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.
Other Names:
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
Other Names:
conditioning regimen:Days -6,-5,-4,-3 Fludarabine 30 mg/m^2/day IV
Other Names:
Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)
Other Names:
|
Experimental: B:Autologous Stem Cell Transplant
Melphalan followed by Autologous 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
Other Names:
Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)
Other Names:
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.
Other Names:
|
Experimental: C:Non-Transplant
Consolidated Chemotherapy for Patients Unable to Receive Transplantation
|
Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression free survival(PFS)
Time Frame: 1 Year post-autograft
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall response(ORR)
Time Frame: 1 Year post-autograft
|
ORR is defined as the proportion of subjects who achieve PR to better rate, according to the IMWG criteria
|
1 Year post-autograft
|
overall survival(OS)
Time Frame: 1 Year post-autograft
|
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
|
Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
Time Frame: 1 year post-allograft
|
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
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Non-relapse Mortality (NRM)
Time Frame: 1 year post-allograft
|
Number of patients with non-relapse mortalities
|
1 year post-allograft
|
Number of Patients Who Had Infections
Time Frame: 1 Year post-autograft
|
Number of patients who had infections
|
1 Year post-autograft
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lu G Qiu, Dr., Institute of Hematology & Blood Diseases Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Leukemia
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Leukemia, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Melphalan
- Fludarabine
Other Study ID Numbers
- IHBDH-IIT2016011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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