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Trial Title:
Safety and ASCT-related Symptom Burden Optimization of Tocilizumab in ASCT Following HD Melphalan Conditioning for Multiple Myeloma Patients
NCT ID:
NCT05855122
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tocilizumab
Description:
Pateients enrolled in Tocilizumab group will receive tocilizumab(8mg/kg) at day -7 before
transfusion of stem cells.
Arm group label:
Tocilizumab
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with multiple myeloma eligible for autologous hematopoietic stem cell
transplantation;
2. Secretory MM should have measurable markers, including:
1. specific M protein value (≥5g/L)；
2. and/or involved flc ≥100mg/L；
3. and/or measurable extramedullary foci (diameter>1cm on CT);
3. Age ≥ 18 years and ≤ 70 years, male or female;
4. PR and above are obtained after induction therapy according to the IMWG response
criteria;
5. Mononuclear cells ≥2×10^8/kg body weight, CD34+ cells≥2×10^6/kg body weight;
6. ECOG 0-2, with life expectance ≥3 months;
7. ALT/AST level ≤2.5 times of the maximum of normal range; total bilirubin≤2 times of
normal maximum；
8. Neutrophil count≥ 1.5×10^9/L, platelet count ≥50×10^9/L;
9. Normal Left ventricular ejection fraction , NYHA stage 1, lung function GOLD stage
1;
10. Willing to accept the possibility of potential adverse events and efficacy
observation by the investigators;
11. Being able to understand and signing the written consent, which should be signed
prior to any procedure of the trial.
Exclusion Criteria:
1. With ≥2 degree of peripheral neuropath or with pain;
2. Having received any of the medicine of the experiment regimen within 30 days prior
to enrollment, pain-relieving radiotherapy is allowed;
3. With severe pulmonary/cardiac disfunction (including history of QT interval
elongation, ventricular tachycardia, ventricular fibrillation, myocardial
infraction) or other severe organ malfunction;
4. Patients in pregnancy or lactation;
5. Allergic constitution or being allergic to any drug within the regimen of the trial;
6. With uncontrolled mental diseases;
7. With active infection;
8. With active hepatitis;
9. HIV positive;
10. History of other malignant tumor within 5 years prior to enrollment; except for the
case of in situ cervical cancer and non-malignant melanoma;
11. With other conditions that the investigators think unfit for the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
chengcheng Fu
Phone:
0512-67781856
Email:
fuzhengzheng@suda.edu.cn
Start date:
April 17, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05855122
