Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
300

Summary

Conditions
Plasma Cell Myeloma
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The duration of the study for the patients will include a period for screening of up to 3 weeks. Patients will continue study treatment until disease progression, unacceptable adverse reaction, patients' wish or other reason of discontinuation. During follow-up, patients who discontinue the study tr...

The duration of the study for the patients will include a period for screening of up to 3 weeks. Patients will continue study treatment until disease progression, unacceptable adverse reaction, patients' wish or other reason of discontinuation. During follow-up, patients who discontinue the study treatment due to progression of the disease will be followed every 3 months (12 weeks) for further anti-myeloma therapies, progression free survival to the second progression and survival, until death or the cut-off date, whichever comes first. Patients who discontinue the study treatment prior to documentation of disease progression will be followed-up every 4 weeks until confirmation of disease progression, and then every 3 months (12 weeks) for further anti-myeloma therapies, progression free survival to the second progression and survival, until death or the cut-off date, whichever comes first. After progression free survival analysis, patients will be followed yearly for 3 years for survival.

Tracking Information

NCT #
NCT03275285
Collaborators
Not Provided
Investigators
Study Director: Clinical Sciences & Operations Sanofi