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a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients

Primary Purpose

Multiple Myeloma, Plasma Cell Leukemia, Extramedullary Plasmacytoma

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Allogeneic Hematopoietic Stem Cell Transplantation
Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2
Melphalan Given IV
Fludarabine Injection
PI and dexamethasone as maintenance therapy
PI+IMids+Dexamethasone as Consolidated Chemotherapy
Sponsored by
Institute of Hematology & Blood Diseases Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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 -

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 -

Sites / Locations

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

A:Allogeneic Stem Cell Transplant Group

B:Autologous Stem Cell Transplant

C:Non-Transplant

Arm Description

Fludarabine+Melphalan followed by Allogeneic SCT.

Melphalan followed by Autologous SCT.

Consolidated Chemotherapy for Patients Unable to Receive Transplantation

Outcomes

Primary Outcome Measures

progression free survival(PFS)
PFS is defined as the duration from the data of registration to either progressive disease or death, whichever comes first.

Secondary Outcome Measures

overall response(ORR)
ORR is defined as the proportion of subjects who achieve PR to better rate, according to the IMWG criteria
overall survival(OS)
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.
Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
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.
Non-relapse Mortality (NRM)
Number of patients with non-relapse mortalities
Number of Patients Who Had Infections
Number of patients who had infections

Full Information

First Posted
June 21, 2019
Last Updated
July 3, 2019
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT04008888
Brief Title
a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients
Official Title
Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Plasma Cell Leukemia, Extramedullary Plasmacytoma, Loss of Chromosome 17p, t(14;16), t(4;14), T(14;20), 1Q21 Amplification, Complex Karyotype

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A:Allogeneic Stem Cell Transplant Group
Arm Type
Experimental
Arm Description
Fludarabine+Melphalan followed by Allogeneic SCT.
Arm Title
B:Autologous Stem Cell Transplant
Arm Type
Experimental
Arm Description
Melphalan followed by Autologous SCT.
Arm Title
C:Non-Transplant
Arm Type
Experimental
Arm Description
Consolidated Chemotherapy for Patients Unable to Receive Transplantation
Intervention Type
Procedure
Intervention Name(s)
Allogeneic Hematopoietic Stem Cell Transplantation
Other Intervention Name(s)
Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HCT, SCT
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2
Other Intervention Name(s)
autologous stem cell transplantation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Melphalan Given IV
Other Intervention Name(s)
Alkeran
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Fludarabine Injection
Other Intervention Name(s)
Fludara
Intervention Description
conditioning regimen:Days -6,-5,-4,-3 Fludarabine 30 mg/m^2/day IV
Intervention Type
Drug
Intervention Name(s)
PI and dexamethasone as maintenance therapy
Other Intervention Name(s)
VD, ID
Intervention Description
Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)
Intervention Type
Drug
Intervention Name(s)
PI+IMids+Dexamethasone as Consolidated Chemotherapy
Other Intervention Name(s)
VRD, IRD, VDPACE, VDECP
Intervention Description
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.
Primary Outcome Measure Information:
Title
progression free survival(PFS)
Description
PFS is defined as the duration from the data of registration to either progressive disease or death, whichever comes first.
Time Frame
1 Year post-autograft
Secondary Outcome Measure Information:
Title
overall response(ORR)
Description
ORR is defined as the proportion of subjects who achieve PR to better rate, according to the IMWG criteria
Time Frame
1 Year post-autograft
Title
overall survival(OS)
Description
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.
Time Frame
1 Year post-autograft
Title
Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
Description
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.
Time Frame
1 year post-allograft
Title
Non-relapse Mortality (NRM)
Description
Number of patients with non-relapse mortalities
Time Frame
1 year post-allograft
Title
Number of Patients Who Had Infections
Description
Number of patients who had infections
Time Frame
1 Year post-autograft

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WEI W SUI, Dr.
Phone
86-022-23909171
Email
suiweiwei@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
GANG AN, Dr.
Phone
86-022-23909171
Email
angang@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu G Qiu, Dr.
Organizational Affiliation
Institute of Hematology & Blood Diseases Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WEI W SUI, Master
Phone
86-022-23909171
Email
suiweiwei@ihcams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

a Clinical Trial of Efficacy and Safety of the Holistic Treatment of Young High-risk Multiple Myeloma Patients

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