Evaluation of efficacy and safety of dose-escalating lenalidomide and dexamethasone (Ld) therapy and adapted therapy adding elotuzumab with insufficient efficacy by Ld therapy in newly diagnosed, transplant ineligible multiple myeloma patients (DELAYED study)
Phase 2
Recruiting
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-UMIN000036377
- Lead Sponsor
- Gifu university hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Not provided
Exclusion Criteria
3) CNS involvement 4) Serologically positive for HIVAb 5) Active malignancy concomitantly existed 6) Pregnant, possible pregnant, or breastfeeding woman 7) Severe infection or clinical complication 8) Severe mental disorder 9) Deep vein thrombosis or pulmonary thrombosis 10) Incompatibility of Lenalidomide, Dexamethasone and Elotuzumab 11) Patients who have been judged by the investigator to be inappropriate for participation in this clinical trial for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VGPR rate
- Secondary Outcome Measures
Name Time Method Overall response rate Complete response rate Efficacy rate of adding Elotuzumab Overall survival Progression-free survival Safety