ELOQUENT-2
Phase 4
Completed
- Conditions
- Multiple Myeloma
- Registration Number
- JPRN-jRCT2080221640
- Lead Sponsor
- Bristol-Myers Squibb K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 640
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>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.<br>Objective Response Rate - The percentage of patients who have a partial or complete response to study therapy.<br>Overall Survival - The period of time from study entry until the date of death or last known date alive.
- Secondary Outcome Measures
Name Time Method safety<br>other<br>-