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 sites534 target enrollmentJune 3, 2022

Overview

No summary available.

Registry

who.int

Start Date

June 3, 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 therapy including lenalidomide and a proteasome inhibitor, and with 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 214
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 320

•\- Participants are excluded from the study if any of the following criteria apply
•Medical conditions:
•\- Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2
•\-Primary refractory multiple myeloma participants
•\-Participants refractory to anti\-CD38 with a wash\-out period inferior to 9 months or intolerant to anti\-CD38 mAb agents
•\-Prior therapy with pomalidomide
•\- Participants with inadequate biological tests.
•\-Significant cardiac dysfunction
•\- Participants diagnosed or treated for another cancer 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
•\-Concomittant plasma cell leukemia