Phase 2 Study of Lenalidomide/dexamethasone with or without Elotuzumab for newly diagnosed MM patients in Japan.

A Phase 2, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma in Japan.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222753

Enrollment

Registered

2015-02-12

Start date

2015-01-15

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

investigational material(s) Generic name etc : Elotuzumab INN of investigational material : Elotuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigatio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Newly diagnosed with symptomatic Multiple Myeloma. Have not received any prior systemic anti-myeloma therapy. Have measurable disease. Are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (65 years and above) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-116 for a subject less than 65 years old. There must be a comorbidity that prevents SCT for a subject less than 65 years old.

Exclusion criteria

Exclusion criteria: Non-secretory or oligo-secretory or free light-chain only myeloma. Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions. Monoclonal Gammopathy of Undetermined Significance (MGUS). Active plasma cell leukemia. Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C.

Design outcomes

Primary

Measure	Time frame
efficacy Objective Response Rate (ORR) of Lenalidomide/Dexamethasone + Elotuzumab therapy. The percentage of patients who have a partial or better response to Lenalidomide/Dexamethasone + Elotuzumab therapy.	—

Secondary

Measure	Time frame
efficacy The difference in ORR between Lenalidomide/Dexamethasone + Elotuzumab and Lenalidomide/Dexamethasone therapy. The difference between the percentage of patients who have a partial or better response to Lenalidomide/Dexamethasone + Elotuzumab therapy or Lenalidomide/Dexamethasone therapy.	—

Countries

Japan

Outcome results

None listed

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