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Trial Title:
A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
NCT ID:
NCT06356571
Condition:
Plasma Cell Myeloma Refractory
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Acetaminophen
Diphenhydramine
Promethazine
Dexamethasone
Methylprednisolone
Montelukast
Conditions: Keywords:
Anti CD38 monoclonal antibody
SARCLISA
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Isatuximab SC-OBDS
Description:
Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS
Arm group label:
Isatuximab in combination with weekly carfilzomib and dexamethasone
Other name:
SAR650984
Other name:
Sarclisa
Intervention type:
Drug
Intervention name:
Montelukast
Description:
Pharmaceutical form:As per local commercial product-Route of administration:Oral
Arm group label:
Isatuximab in combination with weekly carfilzomib and dexamethasone
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
Arm group label:
Isatuximab in combination with weekly carfilzomib and dexamethasone
Intervention type:
Drug
Intervention name:
Acetaminophen
Description:
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
Arm group label:
Isatuximab in combination with weekly carfilzomib and dexamethasone
Intervention type:
Drug
Intervention name:
Diphenhydramine
Description:
Pharmaceutical form:As per local commercial product-Route of administration:Oral (as
premedication) or IV/oral equivalent (for management of infusion reaction)
Arm group label:
Isatuximab in combination with weekly carfilzomib and dexamethasone
Intervention type:
Drug
Intervention name:
Methylprednisolone
Description:
Pharmaceutical form:As per local commercial product-Route of administration:IV
Arm group label:
Isatuximab in combination with weekly carfilzomib and dexamethasone
Intervention type:
Drug
Intervention name:
Carfilzomib
Description:
Pharmaceutical form:As per local commercial product-Route of administration:IV
Arm group label:
Isatuximab in combination with weekly carfilzomib and dexamethasone
Summary:
The primary purpose of this study is to assess the efficacy (overall response rate) of
subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with
weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received
1 to 3 prior lines of therapy.
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. After study treatment discontinuation, participants
will return to the study site 30 days after the last dose of study treatment for the
end-of-treatment (EOT) visit or before further anti-myeloma therapy initiation, whichever
comes first.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants must have a documented diagnosis of 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).
- Participants with relapsed and/or refractory MM with at least 1 prior line of
therapy and no more than 3 prior lines of therapy.
- Contraceptive use by [men and women] should be consistent with local regulations
regarding the methods of contraception for those participating in clinical studies.
- Male participants agree to practice true abstinence or agree to use
contraception while receiving study treatment, during dose interruptions and at
least 5 months following study treatment discontinuation, even if has undergone
a successful vasectomy.
- A female participant is eligible to participate if she is not pregnant, not
breastfeeding, and either is not a female of childbearing potential (FCBP XE "
FCBP " \f Abbreviation \t "female of childbearing potential" ) or agrees to
practice complete abstinence or use contraception.
- Capable of giving signed informed consent.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- 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 < 6 months before
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.
- Participants with contraindication to dexamethasone and/or to carfilzomib.
- Any anti-myeloma drug treatment within 14 days before the first isatuximab
administration, including dexamethasone.
- Prior allogenic HSC transplant with active graft versus host disease (GvHD XE " GvHD
" \f Abbreviation \t "graft versus host disease" ) (GvHD any grade and/or being
under immunosuppressive treatment within the last 2 months).
- Any major procedure within 14 days before the first isatuximab administration:
plasmapheresis, major surgery (kyphoplasty is not considered a major procedure),
radiotherapy.
- Vaccination with a live vaccine within 4 weeks before the first isatuximab
administration. Seasonal flu vaccines that do not contain live virus are permitted.
- Participant not suitable for participation, whatever the reason, as judged by the
Investigator, including medical or clinical conditions, or participants potentially
at risk of noncompliance to study procedures.
The above information is not intended to contain all considerations relevant to the
potential participation in a clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 17, 2024
Completion date:
July 15, 2027
Lead sponsor:
Agency:
Sanofi
Agency class:
Industry
Source:
Sanofi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06356571
