Clinical trial · Interventional
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM
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)
NCT05405166CI-TRIAL-00125355IRAKLIAactive not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This will be 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 will receive at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor (PI). Eligible participants were randomized 1:1 into 1 of 2 study arms: Arm SC: Isatuximab SC + Pd Arm IV: Isatuximab IV + Pd Participants are allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue therapy or any other reason, whichever comes first.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Plasma Cell Myeloma Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Diphenhydramine | Drug | — | UNRESOLVED |
| Isatuximab IV | Drug | Isatuximab | ALIAS |
| Isatuximab SC | Drug | Isatuximab | ALIAS |
| Methylprednisolone | Drug | — | UNRESOLVED |
| Montelukast | Drug | — | UNRESOLVED |
| Paracetamol / Acetaminophen | Drug | — | UNRESOLVED |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Isatuximab Subcutaneous (SC)
- description
- Isatuximab dose will 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). Participants may receive other treatments as background treatment and/or rescue medication.
- interventionNames
- Drug: Isatuximab SC
- Drug: Dexamethasone
- Drug: Pomalidomide
- Drug: Montelukast
- Drug: Paracetamol / Acetaminophen
- Drug: Diphenhydramine
- Drug: Methylprednisolone
- type
- ACTIVE_COMPARATOR
- label
- Isatuximab Intravenous (IV)
- description
- 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). Participants may receive other treatments as background treatment and/or rescue medication.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAilawadhi S, Spicka I, Spencer A, Lu J, Oriol A, Ling S, Schjesvold F, Berkovits A, Hus M, Li C, Dimopoulos MA, Rajnics P, Besisik SK, Hungria V, Custidiano MDR, Parmar G, Leleu X, Li F, Cerchione C, Gomez C, Ishida T, Mateos MV, Buck TT, LeBlanc R, Minarik J, Goldschmidt H, Zhang R, Semiond D, Suzan F, Stefanova-Urena M, Koch V, Moreau P. Isatuximab Subcutaneous by On-Body Injector Versus Isatuximab Intravenous Plus Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Phase III IRAKLIA Study. J Clin Oncol. 2025 Aug;43(22):2527-2537. doi: 10.1200/JCO-25-00744. Epub 2025 Jun 3. PMID 40459178