Phase I study of RO7187797 in patients with Multiple myeloma.
- Conditions
- Multiple myeloma
- Registration Number
- JPRN-jRCT2061220045
- Lead Sponsor
- anki Toshihiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 6
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.
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%.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety, Phamacokinetics<br>Adverse events<br>Dose limiting toxicity<br>pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method Efficacy, Other<br>Response Rates Based on Global Myeloma Working Group (IMWG) Criteria<br>RO7187797 of anti-drug Abs (ADAs)