A study to investigate subcutaneous isatuximab in combination with carfilzomib and dexamethasone in adult participants with relapsed and/or refractory multiple myeloma
- Conditions
- Relapsed/refractory multiple myeloma (RRMM)MedDRA version: 25.0Level: LLTClassification code 10086466Term: Relapsed/refractory multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-002767-30-CZ
- Lead Sponsor
- Sanofi-aventis recherche & developpement
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
-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 3 months following study treatment discontinuation, even if has undergone a successful vasectomy.
Capable of giving signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37
-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 are excluded if: a) Progression on or within 60 days after end of anti-CD38 mAb treatment or failure to achieve at least MR to treatment (ie, refractory to anti-CD38) with a washout period inferior to 9 months before the first isatuximab administration 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 the potential participation in a clinical trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method