Multiple myeloma
Conditions
Interventions
Cevostamab: Cevostamab will be administered intravenously on a 21-day cycle, up to a total of 17 cycles.
Tocilizumab: Intravenous infusion of 8 mg / kg (patient weight 30 kg or more) or 12 mg / kg (pa
Sponsors
Nanki Toshihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eastern Cooperative Oncology Group(ECOG)Performance Status (PS) is 0 or 1. Survival of at least 12 weeks after the date of enrollment was judged to be possible. Relapsed/refractory multiple myeloma for which standard therapy is ineffective and inappropriate.
Exclusion criteria
Exclusion criteria: They have a history of the following immune-mediated side effects of previous immunotherapy: Adverse events Grade 3 or more observed with treatment with anti PD-L1, anti PD-1, or anti CTLA4 therapeutic Abs. Except for Grade 3 endocrine disorders that can be managed with alternative therapies Allogeneic stem cell transplantation was performed in the past. Plasma cell count in peripheral blood exceeds 500/micro liter or plasma cell ratio in differential white blood cell count exceeds 5%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, Phamacokinetics Adverse events Dose limiting toxicity pharmacokinetic parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, Other Response Rates Based on Global Myeloma Working Group (IMWG) Criteria RO7187797 of anti-drug Abs (ADAs) | — |
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed