Thinking of joining a study?

Register your interest

NCT05704049 | Recruiting | Relapsed/Refractory Multiple Myeloma


A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
Sponsor:

Sanofi

Brief Summary:

The main purpose of this study is to measure the efficacy (Myeloma response) of subcutaneous (SC) isatuximab treatment in combination with carfilzomib and dexamethasone in adult participants with RRMM having received 1 to 3 prior lines of therapy. After confirmation of the feasibility of SC isatuximab by manual administration, patient will be randomized to 1 of the 2 delivery method of SC isatuximab.

Condition or disease

Relapsed/Refractory Multiple Myeloma

Intervention/treatment

Isatuximab

Carfilzomib

Dexamethasone

Dexamethasone IV

Phase

Phase 2

Detailed Description:

The duration of the study for a participant will include a period for screening of up to 28 days. A cycle duration is 28 days. Participants will be allowed to continue therapy until disease progression, unacceptable adverse events (AEs), participant request to discontinue treatment, or any other reason, as well as the study treatment is commercially available and reimbursed in the participant's country, or is available from another source, whichever is first. The overall study duration will be of approximately 45 months.

Study Type : Interventional
Estimated Enrollment : 68 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)
Actual Study Start Date : April 5, 2023
Estimated Primary Completion Date : July 17, 2024
Estimated Study Completion Date : November 20, 2026
Arm Intervention/treatment

Experimental: Cohort 1: manual administration

Isatuximab will be administered manually for 8 minutes on Day 1 of Cycle 1 followed by 6 minutes from Day 8 of Cycle 1 and thereafter.

Drug: Isatuximab

Drug: Carfilzomib

Drug: Dexamethasone

Drug: Dexamethasone IV

Experimental: Part 1 Cohort 2: manual administration

Isatuximab will be administered manually for 6 minutes on Day 1 of Cycle 1 and thereafter.

Drug: Isatuximab

Drug: Carfilzomib

Drug: Dexamethasone

Drug: Dexamethasone IV

Experimental: Part 2 Randomized Cohort: OBDS to manual

Isatuximab will be administered via OBDS from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from OBDS to manual administration.

Drug: Isatuximab

Drug: Carfilzomib

Drug: Dexamethasone

Drug: Dexamethasone IV

Experimental: Part 2 Randomized Cohort: Manual to OBDS

Isatuximab will be administered manually from Cycle 1 to 3. For Cycle 4 to 6, the method of administration will be switched for each participant from manual to OBDS administration.

Drug: Isatuximab

Drug: Carfilzomib

Drug: Dexamethasone

Drug: Dexamethasone IV

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Participants must have a documented diagnosis of multiple myeloma (MM)
  • Participants with measurable disease defined as at least one of the following
    • Serum M-protein ≥0.5 g/dL measured using serum protein immunoelectrophoresis and/or
    • Urine M-protein ≥200 mg/24 hours measured using urine protein immunoelectrophoresis and/or
    • Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
    • Participant with relapsed and/or refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy.
    • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP) or agrees to practice complete abstinence or use approved contraception methods.
    • Male participants agree to practice true abstinence or agree to use approved contraception methods while receiving study treatment, during dose interruptions and at least 5 months following study treatment discontinuation, even if has undergone a successful vasectomy.
    • Capable of giving signed informed consent.
    Exclusion Criteria
    • Primary refractory MM defined as participants who have never achieved at least a minimal response (MR) with any treatment during the disease course
    • Participants with prior anti-CD38 treatment if: a) administered <9 months before first isatuximab administration or randomization as applicable or, b) Intolerant to the anti-CD38 previously received
    • Prior treatment with carfilzomib
    • Known history of allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib), prior hypersensitivity to sucrose, histidine (as base and hydrochloride salt), polysorbate 80, or any of the components (active substance or excipient) of study treatment that are not amenable to premedication with steroids, or intolerance to arginine and Poloxamer 188 that would prohibit further treatment with these agents
    • Uncontrolled or active infection with hepatitis A, B, and C virus; known acquired immunodeficiency syndrome (AIDS)-related illness; active primary amyloid light chain (AL) amyloidosis
    • Any severe acute or chronic medical condition which could impair the ability of the participant to participate in the study or interfere with interpretation of study results (eg, systemic infection unless specific anti-infective therapy is employed) or participant unable to comply with the study procedures.
    • The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

Location Details


Please Choose a site



A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Australia, New South Wales

Investigational Site Number : 0360002

Wollongong, New South Wales, Australia, 2500

Recruiting

Australia, Victoria

Investigational Site Number : 0360001

Fitzroy, Victoria, Australia, 3065

Recruiting

Brazil, Rio Grande Do Sul

Hospital Mae de Deus Site Number : 0760002

Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270

Recruiting

Brazil, São Paulo

Clínica São Germano Site Number : 0760003

Sao Paulo, São Paulo, Brazil, 04537-081

Recruiting

Brazil, São Paulo

Hospital das Clinicas de Sao Paulo Site Number : 0760001

Sao Paulo, São Paulo, Brazil, 05403-000

Recruiting

Czechia, Chiba

Investigational Site Number : 2030002

Brno, Chiba, Czechia, 62500

Recruiting

Czechia, Okayama

Investigational Site Number : 2030004

Olomouc, Okayama, Czechia, 77900

Recruiting

Czechia,

Investigational Site Number : 2030003

Ostrava - Poruba, Czechia, 70852

Recruiting

Czechia,

Investigational Site Number : 2030001

Praha 2, Czechia, 12808

Recruiting

Greece,

Investigational Site Number : 3000001

Athens, Greece, 10676

Recruiting

Greece,

Investigational Site Number : 3000002

Athens, Greece, 11528

Recruiting

Greece,

Investigational Site Number : 3000003

Thessaloniki, Greece, 54007

Recruiting

Japan,

Investigational Site Number : 3920001

Kashiwa-shi, Japan, 277-8577

Recruiting

Japan,

Investigational Site Number : 3920002

Okayama-shi, Japan, 701-1192

Recruiting

Portugal,

Investigational Site Number : 6200001

Braga, Portugal, 4710-243

Recruiting

Portugal,

Investigational Site Number : 6200004

Lisboa, Portugal, 1400-038

Recruiting

Portugal,

Investigational Site Number : 6200005

Lisboa, Portugal, 1649-035

Loading...