A randomized, Phase 3, open label study evaluating subcutaneous versus intravenous administration of isatuximab in combination with pomalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma (RRMM)

Sanofi-aventis recherche & developpement0 sites614 target enrollmentSeptember 1, 2022

Overview

No summary available.

Registry

who.int

Start Date

September 1, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sanofi-aventis recherche & developpement

•\- Participants with multiple myeloma who have received at least one prior line of anti\-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination
•\- measurable serum M\-protein (\= 0\.5 g/dL) and/or urine M\-protein (\= 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay \=10 mg/dL and abnormal serum FLC ratio (\<0\.26 or \>1\.65\))
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 246
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 368

•Participants are excluded from the study if any of the following criteria apply:
•\- Primary refractory multiple myeloma participants
•\-Participants with prior anti\-CD38 treatment: (a) administered a less than 9 months before randomization or, (b) intolerant to the anti\-CD38 previously received
•\- Prior therapy with pomalidomide
•\- Participants with inadequate biological tests.
•\- Significant cardiac dysfunction
•\- Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy
•\- Concomitant plasma cell leukemia
•\- Active primary amyloid\-light chain amyloidosis
•\- Known acquired immunodeficiency syndrome (AIDS)\-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment