Full Title:: 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)

Summary/Purpose:: 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.

Detailed Description:: 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.

Treatments:: Drug : Isatuximab IV

Pharmaceutical form: Concentrate solution for IV infusion; Route of administration: Intravenous; Drug : Isatuximab SC

Pharmaceutical form: Solution for subcutaneous administration; Route of administration: Subcutaneous (SC); Drug : Dexamethasone

Pharmaceutical form: Tablet; Route of administration: Oral; Drug : Pomalyst or equivalent

Pharmaceutical form: hard capsules; Route of administration: Oral

Study Arms:: Experimental : Isatuximab Subcutaneous (SC)
Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).; Active Comparator : Isatuximab Intravenous (IV)
Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days).

Study Design:: Allocation: Randomized; Intervention Model: Parallel Assignment; Primary Purpose: Treatment; Masking: None (Open Label)

Eligibility criteria:

Inclusion Criteria:

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)).

Exclusion Criteria:

Primary refractory multiple myeloma participants
Participants with prior anti-CD38 treatment: (a) administered 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
Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed.
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.

Locations / Centres:

Investigational Site Number : 1240001, Toronto, Ontario – Recruiting

Investigational Site Number : 1240004, Greenfield Park, Quebec – Recruiting

Investigational Site Number : 1240003, Montreal, Quebec – Recruiting

Contacts:: Name: Trial Transparency email recommended (Toll free for US & Canada)
Phone: 800-633-1610
Extension: Option 6
Email: [email protected]

Listed location countries:: Argentina; Australia; Brazil; Canada; Chile; China; Czechia; France; Germany; Greece; Hungary; Italy; Japan; Norway; Poland; Spain; Sweden; Taiwan; Turkey; United Kingdom; United States

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM (IRAKLIA)