Safety and ASCT-related Symptom Burden Optimization of Tocilizumab in ASCT Following HD Melphalan Conditioning for Multiple Myeloma Patients
Multiple Myeloma
About this trial
This is an interventional supportive care trial for Multiple Myeloma
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.
Sites / Locations
- The First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Tocilizumab
no-Tocilizumab