A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (ONO-7057-08/20180015)
Phase 3
Completed
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Registration Number
- JPRN-jRCT2080224738
- Lead Sponsor
- ONO PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 460
Inclusion Criteria
1.Subject has multiple myeloma with documented relapse or progression after most recent myeloma treatment.
2.Subject has measurable disease lesion defined in the protocol.
3.Subjects must have received at least 1 but not more than 3 prior lines of therapy for multiple myeloma.
Exclusion Criteria
1.Waldenstrom macroglobulinemia
2.POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
3.Plasma cell leukemia.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy
- Secondary Outcome Measures
Name Time Method efficacy<br>other<br>Progression free survival (PFS), Convenience as measured by the Patient-reported convenience with carfilzomib dosing schedule question etc.