SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

  • End date
    Oct 23, 2026
  • participants needed
  • sponsor
Updated on 7 October 2022


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.


Two study arms will be treated in 4-week cycles until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.

Condition Plasma Cell Myeloma Recurrent
Treatment Pomalidomide, Dexamethasone, Isatuximab IV, Isatuximab SC
Clinical Study IdentifierNCT05405166
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

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 (≥
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))

Exclusion Criteria

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
Active primary amyloid-light (AL) amyloidosis
Known acquired immunodeficiency syndrome (AIDS)-related illness or known human
immunodeficiency virus (HIV) disease requiring antiviral treatment
Hepatitis A, B, or C active infection
Women of childbearing potential or male participant with women of childbearing
potential who do not agree to use highly effective method of birth control
The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial
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