SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients
Last updated on April 2022Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 39
Summary
- Conditions
- Plasma Cell Myeloma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study duration for an individual patient will include a screening period for inclusion of up to 21 days, and at least 4 weeks of treatment in the absence of severe adverse reaction, dose limiting toxicity or disease progression plus up to 60 days post-treatment follow up. The treatment period ma...
The study duration for an individual patient will include a screening period for inclusion of up to 21 days, and at least 4 weeks of treatment in the absence of severe adverse reaction, dose limiting toxicity or disease progression plus up to 60 days post-treatment follow up. The treatment period may continue until disease progression, intolerable toxicity, or Investigator, sponsor, or patient decision to discontinue therapy. After study treatment discontinuation, an end of treatment (EOT) visit will be done at 30 days to assess safety, and at 30 and 60 days for anti-drug antibody (ADA) and PK. If the ADA is positive or inconclusive at day 60, then PK and ADA will be repeated every 30 days until ADA is negative. Patients who discontinue treatment for reasons other than progression of disease will be followed monthly until progression, initiation of subsequent therapy, or until the primary analysis cutoff date, whichever comes first.
Locations
- Columbus, Ohio, 43210
- Saint Louis, Missouri, 63110
- Tampa, Florida, 33612
- New York, New York, 10021
- San Francisco, California, 94117
- ...
- Columbus, Ohio, 43210
- Saint Louis, Missouri, 63110
- Tampa, Florida, 33612
- New York, New York, 10021
- San Francisco, California, 94117
Tracking Information
- NCT #
- NCT01749969
- Collaborators
- Not Provided
- Investigators
- Study Director: Clinical Sciences & Operations Sanofi