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Safety and ASCT-related Symptom Burden Optimization of Tocilizumab in ASCT Following HD Melphalan Conditioning for Multiple Myeloma Patients

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
The First Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with multiple myeloma eligible for autologous hematopoietic stem cell transplantation; Secretory MM should have measurable markers, including: specific M protein value (≥5g/L); and/or involved flc ≥100mg/L; and/or measurable extramedullary foci (diameter>1cm on CT); Age ≥ 18 years and ≤ 70 years, male or female; PR and above are obtained after induction therapy according to the IMWG response criteria; Mononuclear cells ≥2×10^8/kg body weight, CD34+ cells≥2×10^6/kg body weight; ECOG 0-2, with life expectance ≥3 months; ALT/AST level ≤2.5 times of the maximum of normal range; total bilirubin≤2 times of normal maximum; Neutrophil count≥ 1.5×10^9/L, platelet count ≥50×10^9/L; Normal Left ventricular ejection fraction , NYHA stage 1, lung function GOLD stage 1; Willing to accept the possibility of potential adverse events and efficacy observation by the investigators; Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial. Exclusion Criteria: With ≥2 degree of peripheral neuropath or with pain; Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed; With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction; Patients in pregnancy or lactation; Allergic constitution or being allergic to any drug within the regimen of the trial; With uncontrolled mental diseases; With active infection; With active hepatitis; HIV positive; History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma; With other conditions that the investigators think unfit for the trial.

Sites / Locations

  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tocilizumab

no-Tocilizumab

Arm Description

Outcomes

Primary Outcome Measures

MDASI questionnaire
MDASI, also as the M. D. Anderson Symptom Inventory, is a brief measure of the severity and impact of cancer related symptoms. Each symptom is rated on an 11-point scale (0 -10) to indicate the presence and severity of the symptom, with 0 meaning "not present" and 10 meaning "as bad as you can imagine." Each symptom is rated at its worst in the last 24 hours.
Adverse events
recording adverse events according to CTCAE5.0

Secondary Outcome Measures

Full Information

First Posted
May 3, 2023
Last Updated
June 1, 2023
Sponsor
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT05855122
Brief Title
Safety and ASCT-related Symptom Burden Optimization of Tocilizumab in ASCT Following HD Melphalan Conditioning for Multiple Myeloma Patients
Official Title
Study of Safety and ASCT-related Symptom Burden Optimization of Tocilizumab in ASCT Following High-dose Melphalan Conditioning in Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Background: Autologous hematopoietic stem cell transplantation(ASCT) is an important part treatment for patients with multiple myeloma. Retrospective analysis from our center showed that incidence of oral mucositis and gastrointestinal symptoms was higher during ASCT for melphalan as conditioning regimen in patients with multiple myeloma. Objective: Safety and optimization of ASCT-related symptom burden of tocilizumab for melphalan as a conditioning regimen in ASCT for multiple myeloma is explored. Methods: The patient who is enrolled will be randomly divided into two groups in a proportion of 1:1 to respectively receive tocilizumab(8mg/kg) at day -7 before transfusion of stem cells or not. There will be enroll 48 patients according to inclusion and exclusion criteria totally. Adverse events and MDASI score during ASCT between two groups will be recorded and analyzed. Primary endpoint: MDASI, Security; Secondary endpoints: time to neutrophil engraftment; time of platelet implantation; efficacy (ORR) after autologous hematopoietic stem cell transplantation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tocilizumab
Arm Type
Experimental
Arm Title
no-Tocilizumab
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
Pateients enrolled in Tocilizumab group will receive tocilizumab(8mg/kg) at day -7 before transfusion of stem cells.
Primary Outcome Measure Information:
Title
MDASI questionnaire
Description
MDASI, also as the M. D. Anderson Symptom Inventory, is a brief measure of the severity and impact of cancer related symptoms. Each symptom is rated on an 11-point scale (0 -10) to indicate the presence and severity of the symptom, with 0 meaning "not present" and 10 meaning "as bad as you can imagine." Each symptom is rated at its worst in the last 24 hours.
Time Frame
day -7~day 100 after stem cells transfusion
Title
Adverse events
Description
recording adverse events according to CTCAE5.0
Time Frame
day -7~day 100 after stem cells transfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with multiple myeloma eligible for autologous hematopoietic stem cell transplantation; Secretory MM should have measurable markers, including: specific M protein value (≥5g/L); and/or involved flc ≥100mg/L; and/or measurable extramedullary foci (diameter>1cm on CT); Age ≥ 18 years and ≤ 70 years, male or female; PR and above are obtained after induction therapy according to the IMWG response criteria; Mononuclear cells ≥2×10^8/kg body weight, CD34+ cells≥2×10^6/kg body weight; ECOG 0-2, with life expectance ≥3 months; ALT/AST level ≤2.5 times of the maximum of normal range; total bilirubin≤2 times of normal maximum; Neutrophil count≥ 1.5×10^9/L, platelet count ≥50×10^9/L; Normal Left ventricular ejection fraction , NYHA stage 1, lung function GOLD stage 1; Willing to accept the possibility of potential adverse events and efficacy observation by the investigators; Being able to understand and signing the written consent, which should be signed prior to any procedure of the trial. Exclusion Criteria: With ≥2 degree of peripheral neuropath or with pain; Having received any of the medicine of the experiment regimen within 30 days prior to enrollment, pain-relieving radiotherapy is allowed; With severe pulmonary/cardiac disfunction (including history of QT interval elongation, ventricular tachycardia, ventricular fibrillation, myocardial infraction) or other severe organ malfunction; Patients in pregnancy or lactation; Allergic constitution or being allergic to any drug within the regimen of the trial; With uncontrolled mental diseases; With active infection; With active hepatitis; HIV positive; History of other malignant tumor within 5 years prior to enrollment; except for the case of in situ cervical cancer and non-malignant melanoma; With other conditions that the investigators think unfit for the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chengcheng Fu, PhD
Phone
051267781856
Email
fuzhengzheng@suda.edu.cn
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chengcheng Fu
Phone
0512-67781856
Email
fuzhengzheng@suda.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and ASCT-related Symptom Burden Optimization of Tocilizumab in ASCT Following HD Melphalan Conditioning for Multiple Myeloma Patients

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