Optimizing symptom management with tocilizumab for multiple myeloma patients undergoing stem cell transplantation

Study of Safety and ASCT-related Symptom Burden Optimization of Tocilizumab in ASCT Following High-dose Melphalan Conditioning in Patients With Multiple Myeloma

This study is testing if tocilizumab can help reduce symptoms for multiple myeloma patients getting stem cell transplants.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: tocilizumab
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT05855122 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of tocilizumab in reducing symptom burden during autologous hematopoietic stem cell transplantation (ASCT) for patients with multiple myeloma. Participants will be randomly assigned to receive either tocilizumab or a placebo prior to stem cell infusion. The study aims to assess adverse events and symptom severity using the MD Anderson Symptom Inventory (MDASI) score, along with secondary endpoints related to blood cell recovery times. A total of 48 patients will be enrolled based on specific inclusion and exclusion criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with multiple myeloma who are eligible for ASCT and have measurable disease markers.

Not a fit: Patients with severe comorbidities or those who do not meet the eligibility criteria for ASCT may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the symptom burden associated with ASCT in multiple myeloma patients, improving their quality of life during treatment.

How similar studies have performed: While the specific use of tocilizumab in this context may be novel, similar studies have shown promise in managing symptom burden in other hematological conditions.

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.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: chengcheng Fu, PhD

Conditions Multiple Myeloma