Les informations présentées dans l’Outil de recherche personnalisé d’essais cliniques de Myélome Canada sont issues de la base de données des essais cliniques internationaux du site
ClinicalTrials.gov,
répertoriées par la U.S. National Library of Medicine. Bien que le menu soit en français, les détails des études ne sont offerts qu’en anglais.
SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM (IRAKLIA)
*Les informations de l'essai contenues sur cette page ont été récupérées du site ClinicalTrials.gov. Cliquez ici pour voir cet essai sur ClinicalTrials.gov.
- Titre complet:
- 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)
- Stade ou Condition:
- Plasma Cell Myeloma Recurrent
- Phase d'étude:
- Phase 3
- Résumé:
- 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.
- Description détaillée:
- 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.
- Traitements:
- 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
- Groupes d'étude:
- 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).
- Type d'étude:
- Interventional
- Protocole de l'étude:
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Statut du recrutement:
- En cours
- Critères d'admissibilités:
-
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)).
- 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.
- Lieux / Centres:
-
Investigational Site Number : 1240001, Toronto, Ontario – En cours
Investigational Site Number : 1240004, Greenfield Park, Quebec – En cours
Investigational Site Number : 1240003, Montreal, Quebec – En cours
- Contacts:
- Name: Trial Transparency email recommended (Toll free for US & Canada)
Phone: 800-633-1610
Extension: Option 6
Email: [email protected]
- Publications:
- ???
- Date d’affichage:
- 2022-06-06
- Date de début:
- June 23, 2022
- Dernière mise à jour:
- 2024-03-05
- Nombre d'inscriptions anticipées:
- 534
- Date de fin prévue:
- 2027-02-15
- Date de fin prévue de l'étude primaire:
- 2024-05-23
- Condition:
- Plasma Cell Myeloma Recurrent
- Genre:
- All
- Âge:
- 18 Years-N/A
- Accepte des bénévoles en santé:
- No
- Pays participants:
- Argentina
- Australia
- Brazil
- Canada
- Chile
- China
- Czechia
- France
- Germany
- Greece
- Hungary
- Italy
- Japan
- Norway
- Poland
- Spain
- Sweden
- Taiwan
- Turkey
- United Kingdom
- United States
- Numéro d’identification:
- NCT05405166
- Autres numéros d'identification de l'étude:
- EFC15951
- Comité de suivi des données:
- Yes
- Produit réglementé par la FDA (É-U):
- Yes
- IPD Sharing Statement :
- ???
- Responsables de l’étude:
-
Sponsor
- Commanditaires de l’étude:
- lead_sponsor
Sanofi
Industry
- Collaborators:
- ???
- Chercheurs:
- Clinical Sciences & Operations Sanofi
- Protocol Registration and Results System:
- ???
- Date de vérification:
- 2024-03-01