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
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
64 participants
INTERVENTIONAL
2025-03-17
2027-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Isatuximab in combination with weekly carfilzomib and dexamethasone
Participants will receive isatuximab via SC-OBDS administration in combination with weekly carfilzomib and dexamethasone. Isatuximab will be administered on days 1, 8, 15 and 22 for Cycle 1 and then on days 1, 15 for subsequent cycles. Carfilzomib will be administered intravenously (IV) at a starting dose on Day 1 of Cycle 1 and then escalated dose on Days 8 and 15 of Cycle 1, followed by Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be given on Days 1, 8, 15, and 22 of Cycle 1 and then on Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be administered IV on Cycle 1 Day 1, and IV or PO in the subsequent administrations. 1 cycle = 28 days.
Isatuximab SC-OBDS
Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS
Montelukast
Pharmaceutical form:As per local commercial product-Route of administration:Oral
Dexamethasone
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
Acetaminophen
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
Diphenhydramine
Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)
Methylprednisolone
Pharmaceutical form:As per local commercial product-Route of administration:IV
Carfilzomib
Pharmaceutical form:As per local commercial product-Route of administration:IV
Interventions
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Isatuximab SC-OBDS
Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS
Montelukast
Pharmaceutical form:As per local commercial product-Route of administration:Oral
Dexamethasone
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
Acetaminophen
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
Diphenhydramine
Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)
Methylprednisolone
Pharmaceutical form:As per local commercial product-Route of administration:IV
Carfilzomib
Pharmaceutical form:As per local commercial product-Route of administration:IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* Participants who are refractory to 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic in Arizona - Phoenix- Site Number : 8400058
Phoenix, Arizona, United States
Private Practice - Dr. James R. Berenson- Site Number : 8400044
West Hollywood, California, United States
Smilow Cancer Center at Yale-New Haven- Site Number : 8400020
New Haven, Connecticut, United States
Maryland Oncology Hematology- Site Number : 8400038
Washington D.C., District of Columbia, United States
Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031
Fort Lauderdale, Florida, United States
Mayo Clinic in Florida- Site Number : 8400002
Jacksonville, Florida, United States
Florida Cancer Specialists- Site Number : 8400030
Lake Mary, Florida, United States
The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054
Lakeland, Florida, United States
D&H Pompano Research Center- Site Number : 8400049
Margate, Florida, United States
Millennium Oncology - Pembroke Pines- Site Number : 8400011
Pembroke Pines, Florida, United States
BRCR Global- Site Number : 8400008
Plantation, Florida, United States
Pontchartrain Cancer Center - Covington- Site Number : 8400046
Covington, Louisiana, United States
Beth Israel Deaconess Medical Center - Boston- Site Number : 8400005
Boston, Massachusetts, United States
Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036
Dearborn, Michigan, United States
Hematology Oncology Consultants - Royal Oak- Site Number : 8400039
Royal Oak, Michigan, United States
Alliance for Multispeciality Research - Kansas City- Site Number : 8400056
Kansas City, Missouri, United States
Washington University- Site Number : 8400007
St Louis, Missouri, United States
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021
Hackensack, New Jersey, United States
San Juan Oncology Associates- Site Number : 8400016
Farmington, New Mexico, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003
New York, New York, United States
Duke University Medical Center- Site Number : 8400018
Durham, North Carolina, United States
Gabrail Cancer Center- Site Number : 8400010
Canton, Ohio, United States
University of Cincinnati Medical Center- Site Number : 8400043
Cincinnati, Ohio, United States
Oncology Hematology Care - Kenwood- Site Number : 8400014
Cincinnati, Ohio, United States
Roper Saint Francis Healthcare- Site Number : 8400013
Charleston, South Carolina, United States
Prisma Health Cancer Institute - Greenville- Site Number : 8400019
Greenville, South Carolina, United States
Gibbs Cancer Center-Spartanburg Medical Center- Site Number : 8400001
Spartanburg, South Carolina, United States
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road- Site Number : 8400035
Knoxville, Tennessee, United States
University of Tennessee Medical Center- Site Number : 8400006
Knoxville, Tennessee, United States
Virginia Cancer Specialists- Site Number : 8400045
Fairfax, Virginia, United States
SSM Health Dean Medical Group - Wisconsin - Madison- Site Number : 8400009
Madison, Wisconsin, United States
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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LPS18183 Plain Language Results Summary
Other Identifiers
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U1111-1298-7348
Identifier Type: OTHER
Identifier Source: secondary_id
LPS18183
Identifier Type: -
Identifier Source: org_study_id
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