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)

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) - 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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036377

Enrollment

Registered

2019-04-02

Start date

2019-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Interventions

Starting dose of Lenalidomide is 10mg. Adding elotuzumab with insufficient efficacy by Lenalidomide therapy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Newly diagnosed, transplant ineligible multiple myeloma 2) Aged 20 or older. 3) Patients that can comply with regulations on the study protocol. 4) Patients in which lenalidomide drug management procedures (RevMate) can be followed. 5) Patients who fall under at least one point in IMWG report and are judged by the attending physician as necessary to reduce the initial dose of lenalidomide. 6) Patients meet all following standard Absolute neutrophil count >= 1,000/mm3, Platelet count >= 50,000/mm3, Total bilirubin < 3 times facility criteria, AST and ALT < 5 times facility criteria, Creatinine Clearance >= 30ml/min. 7) Written informed consent obtained.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
VGPR rate	—

Secondary

Measure	Time frame
Overall response rate Complete response rate Efficacy rate of adding Elotuzumab Overall survival Progression-free survival Safety	—

Countries

Japan

Contacts

Public ContactJunichi Kitagawa

Gifu University Hospital Department of Hematology

jkita-gif@umin.ac.jp058-230-6308

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026