At a glance
ClinicalIndex Comparison Record- ✓Multiple myeloma with at least one prior line of anti-myeloma therapy including lenalidomide and proteasome inhibitor
- ✓Measurable disease by serum M-protein ≥0.5 g/dL, or urine M-protein ≥200 mg/24 hours, or involved serum free light chain ≥10 mg/dL with abnormal ratio
- ✕Primary refractory multiple myeloma
- ✕Prior anti-CD38 treatment within 9 months before randomization or intolerance to prior anti-CD38 therapy
- ✕Prior therapy with pomalidomide
- ✕Significant cardiac dysfunction
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Isatuximab IV, Isatuximab SC, and 6 other interventions for Plasma Cell Myeloma Recurrent. Active but no longer recruiting, targeting 531 participants across 146 sites in 21 countries.
Detailed Summary
This is a randomized, multicenter, Phase 3, open-label study evaluating subcutaneous (SC) vs intravenous (IV) administration of isatuximab in combination with pomalidomide and dexamethasone (Pd) in RRMM patients (study participants) who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants will be randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Study Details
Timeline
Interventions
Pharmaceutical form: Concentrate solution for IV infusion; Route of administration: Intravenous
Pharmaceutical form: Solution for subcutaneous administration; Route of administration: Subcutaneous (SC)
Pharmaceutical form: Tablet; Route of administration: Oral
Pharmaceutical form: hard capsules; Route of administration: Oral
Pharmaceutical form: As per local commercial product; Route of administration: Oral; Auxiliary Medicinal Product (AxMP) i.e., background treatment; ATC code: H02AB02
Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: R03DC03
Pharmaceutical form: As per local commercial product; Route of administration: Oral; AxMP i.e., background treatment; ATC code: N02BE01
Pharmaceutical form: As per local commercial product; Route of administration: As premedication- oral; for management of infusion reactions-IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: R06AA02
Pharmaceutical form: As per local commercial product; Route of administration: As premedication-IV; for management of infusion reactions- IV (or oral equivalent); AxMP i.e., background treatment and rescue medication (in case of infusion reactions); ATC code: H02AB04