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

NCT05855122 | Unknown Phase 4

• 1 other identifier: Tocilizumab-ASCT-MM08
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• 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.

  day -7~day 100 after stem cells transfusion

• Adverse events

  recording adverse events according to CTCAE5.0

  day -7~day 100 after stem cells transfusion

Study Arms (2)

Tocilizumab

EXPERIMENTAL

Drug: Tocilizumab

no-Tocilizumab

NO INTERVENTION

Interventions

Tocilizumab DRUG

Pateients enrolled in Tocilizumab group will receive tocilizumab(8mg/kg) at day -7 before transfusion of stem cells.

Tocilizumab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

chengcheng Fu, PhD

CONTACT

051267781856; fuzhengzheng@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 11, 2023
• Study Start: April 17, 2023
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)