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

RecruitingPhase 2

A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM)

Who can join

Ages 18 and older · All sexes

Full 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.
* 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.

About the study

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.

What is being tested

Sponsor: Sanofi · Participants: 64 · Started: Mar 17, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06356571

Locations in the U.S.

ArizonaMayo Clinic in Arizona - Phoenix- Site Number : 8400058, Phoenix
CaliforniaLos Angeles Hematology Oncology Medical Group- Site Number : 8400027, Los Angeles
Private Practice - Dr. James R. Berenson- Site Number : 8400044, West Hollywood
ConnecticutSmilow Cancer Center at Yale-New Haven- Site Number : 8400020, New Haven
District of ColumbiaMaryland Oncology Hematology- Site Number : 8400038, Washington D.C.
FloridaLife Clinical Trials - Coral Springs- Site Number : 8400055, Coral Springs
Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031, Fort Lauderdale
Mayo Clinic in Florida- Site Number : 8400002, Jacksonville
The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054, Lakeland
D&H Pompano Research Center- Site Number : 8400049, Margate
Millennium Oncology - Pembroke Pines- Site Number : 8400011, Pembroke Pines
BRCR Global- Site Number : 8400008, Plantation
Florida Cancer Specialists - North- Site Number : 8400030, St. Petersburg
LouisianaPontchartrain Cancer Center - Covington- Site Number : 8400046, Covington
MassachusettsBeth Israel Deaconess Medical Center - Boston- Site Number : 8400005, Boston
MichiganMichigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036, Dearborn
Hematology Oncology Consultants - Royal Oak- Site Number : 8400039, Royal Oak
MissouriAlliance for Multispeciality Research - Kansas City- Site Number : 8400056, Kansas City
Washington University- Site Number : 8400007, St Louis
New JerseyHackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021, Hackensack
New MexicoSan Juan Oncology Associates- Site Number : 8400016, Farmington
New YorkMemorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003, New York
North CarolinaDuke University Medical Center- Site Number : 8400018, Durham
OhioGabrail Cancer Center- Site Number : 8400010, Canton
Oncology Hematology Care - Kenwood- Site Number : 8400014, Cincinnati
University of Cincinnati Medical Center- Site Number : 8400043, Cincinnati
South CarolinaRoper Saint Francis Healthcare- Site Number : 8400013, Charleston
Prisma Health Cancer Institute - Greenville- Site Number : 8400019, Greenville
Gibbs Cancer Center & Research Institute - Spartanburg- Site Number : 8400001, Spartanburg
TennesseeTennessee Cancer Specialists - Knoxville - Old Weisgarber Road- Site Number : 8400035, Knoxville
University of Tennessee Medical Center- Site Number : 8400006, Knoxville
Tennessee Oncology Nashville- Site Number : 8400012, Nashville
VirginiaNorthern Virginia Oncology Group- Site Number : 8400045, Fairfax
WisconsinSSM Health Dean Medical Group - Wisconsin - Madison- Site Number : 8400009, Madison

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.