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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

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:

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 -

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

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

NCT ID

NCT04008888

First Posted

June 21, 2019

Last Updated

July 3, 2019

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

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

suiweiwei@ihcams.ac.cn

First Name & Middle Initial & Last Name or Official Title & Degree

GANG AN, Dr.

Phone

86-022-23909171

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

suiweiwei@ihcams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD

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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