jRCT2080223979CompletedPhase 1
A multicenter, open-label, non-controlled, dose-escalation study in patients with relapsed/refractory multiple myeloma and non-Hodgkin's lymphoma (ONO-7705-01)
ONO PHARMACEUTICAL CO.,LTD.1 site18 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Intervention Model
- Multicenter, Open-label, Non-controlled, Dose-escalation Study
- Primary Purpose
- Treatment Purpose
Eligibility Criteria
- Ages
- 20age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Patients who are able to stay in hospital from a day before starting the study drug of the first course until the end of the relevant tests on Day 28
- •Patients with relapsed/refractory MM or NHL
- •Patients who have received two or more lines of therapies for MM or NHL
Exclusion Criteria
- •Patients with plasma cell leukemia (defined as a peripheral blood plasma cell count > 2.0*10^9/L by the standard classification method)
- •Patients with primary amyloidosis
- •Patients with POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M protein, and skin changes)
- •Patients with acute lymphocytic leukemia
- •Patients with lymphoblastic lymphoma
- •Patients with Burkitt's lymphoma or Richter's Syndrome
Outcomes
Primary Outcomes
-
safety tolerability of ONO-7705 in relapsed/refractory MM and NHL patients
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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