ELOQUENT-2

Phase 3, Randomized, Open Label Trial of Lenalidomide/dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221640

Enrollment

640

Registered

2011-11-07

Start date

2011-10-27

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(BMS-901608) INN of investigational material : Elotuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for

Days 1 and 15 (cycles 3 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug. control material(s) Generic name etc : Lenalidomide INN of investigational ma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Documented progression from most recent line of therapy. 1-3 prior lines of therapy. Measurable disease. Life expectancy 3 months and more. Prior treatment with Lenalidomide permitted if: 1.Best response achieved was more than Partial Response (PR). 2.Patient was not refractory. 3.Patient did not discontinue due to a Grade 3 and more related adverse event. 4.Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression

Exclusion criteria

Exclusion criteria: Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma. Active plasma cell leukemia. Known Human immunodeficiency virus (HIV) infection or active hepatitis A, B, or C.

Design outcomes

Primary

Measure	Time frame
efficacy Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment. Objective Response Rate - The percentage of patients who have a partial or complete response to study therapy. Overall Survival - The period of time from study entry until the date of death or last known date alive.	—

Measure

Time frame

efficacy Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment. Objective Response Rate - The percentage of patients who have a partial or complete response to study therapy. Overall Survival - The period of time from study entry until the date of death or last known date alive.

—

Secondary

Measure	Time frame
safety other -	—

Countries

Europe, Japan, North America, Oceania, South America

Outcome results

None listed

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