Phase I study of RO7187797 in patients with Multiple myeloma.

JRCT ID: jRCT2061220045

Registered date:16/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Multiple myeloma
• Date of first enrollment: 29/11/2022
• Target sample size: 6
• Study type: Interventional

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 Outcome

Safety, Phamacokinetics
Adverse events
Dose limiting toxicity
pharmacokinetic parameters

Secondary Outcome

Efficacy, 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 maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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%.

Related Information

• Primary Sponsor: Nanki Toshihiro