NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2061220045

Registered date:16/07/2022

Phase I study of RO7187797 in patients with Multiple myeloma.

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedMultiple myeloma
Date of first enrollment29/11/2022
Target sample size6
Countries of recruitment
Study typeInterventional
Intervention(s)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 (patient weight less than 30 kg) at a time.

Outcome(s)

Primary OutcomeSafety, Phamacokinetics Adverse events Dose limiting toxicity pharmacokinetic parameters
Secondary OutcomeEfficacy, Other Response Rates Based on Global Myeloma Working Group (IMWG) Criteria RO7187797 of anti-drug Abs (ADAs)

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaEastern 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.
Exclude criteriaThey 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%.

Related Information

Contact

Public contact
Name Clinical trials information
Address 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324
Telephone +81-120-189-706
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation Chugai Pharmaceutical Co., Ltd.
Scientific contact
Name Toshihiro Nanki
Address 1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo Tokyo Japan 103-8324
Telephone +81-120-189-706
E-mail clinical-trials@chugai-pharm.co.jp
Affiliation Division of Rheumatology, Department of Internal Medicine, School of Medicine, Toho University