Actively Recruiting
A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
Led by Sanofi · Updated on 2026-02-23
64
Participants Needed
34
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a documented diagnosis of multiple myeloma.
- Participants must have measurable disease defined by serum M-protein 0.5 g/dL or urine M-protein 200 mg/24 hours or involved serum free light chain 10 mg/dL with abnormal ratio.
- Participants must have relapsed and/or refractory multiple myeloma with 1 to 3 prior lines of therapy.
- Male participants must agree to use contraception or practice abstinence during and for 5 months after treatment.
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or agree to use contraception or abstinence.
- Participants must be able to provide signed informed consent.
You will not qualify if you...
- Participants with primary refractory multiple myeloma who never achieved at least minimal response.
- Prior anti-CD38 treatment administered less than 6 months before isatuximab or intolerance to prior anti-CD38.
- Participants refractory to carfilzomib.
- Known allergy to captisol, sucrose, histidine, polysorbate 80, arginine, Poloxamer 188, or any study treatment component not manageable with steroids.
- Contraindication to dexamethasone or carfilzomib.
- Any anti-myeloma treatment within 14 days before first isatuximab dose.
- Prior allogenic stem cell transplant with active graft versus host disease or recent immunosuppressive treatment.
- Major procedures within 14 days before first isatuximab dose except kyphoplasty.
- Vaccination with live vaccine within 4 weeks before first isatuximab dose.
- Any medical or clinical condition or risk of noncompliance judged unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 34 locations
1
Mayo Clinic in Arizona - Phoenix- Site Number : 8400058
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Los Angeles Hematology Oncology Medical Group- Site Number : 8400027
Los Angeles, California, United States, 90017
Actively Recruiting
3
Private Practice - Dr. James R. Berenson- Site Number : 8400044
West Hollywood, California, United States, 90069
Actively Recruiting
4
Smilow Cancer Center at Yale-New Haven- Site Number : 8400020
New Haven, Connecticut, United States, 06511
Actively Recruiting
5
Maryland Oncology Hematology- Site Number : 8400038
Washington D.C., District of Columbia, United States, 20017
Actively Recruiting
6
Life Clinical Trials - Coral Springs- Site Number : 8400055
Coral Springs, Florida, United States, 33071
Actively Recruiting
7
Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031
Fort Lauderdale, Florida, United States, 33309
Actively Recruiting
8
Mayo Clinic in Florida- Site Number : 8400002
Jacksonville, Florida, United States, 32224
Actively Recruiting
9
The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054
Lakeland, Florida, United States, 33812
Actively Recruiting
10
D&H Pompano Research Center- Site Number : 8400049
Margate, Florida, United States, 33063
Actively Recruiting
11
Millennium Oncology - Pembroke Pines- Site Number : 8400011
Pembroke Pines, Florida, United States, 33024
Actively Recruiting
12
BRCR Global- Site Number : 8400008
Plantation, Florida, United States, 33322
Actively Recruiting
13
Florida Cancer Specialists - North- Site Number : 8400030
St. Petersburg, Florida, United States, 33705
Actively Recruiting
14
Pontchartrain Cancer Center - Covington- Site Number : 8400046
Covington, Louisiana, United States, 70433
Actively Recruiting
15
Beth Israel Deaconess Medical Center - Boston- Site Number : 8400005
Boston, Massachusetts, United States, 02215
Actively Recruiting
16
Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036
Dearborn, Michigan, United States, 48126
Actively Recruiting
17
Hematology Oncology Consultants - Royal Oak- Site Number : 8400039
Royal Oak, Michigan, United States, 48073
Actively Recruiting
18
Alliance for Multispeciality Research - Kansas City- Site Number : 8400056
Kansas City, Missouri, United States, 64114
Actively Recruiting
19
Washington University- Site Number : 8400007
St Louis, Missouri, United States, 63110
Actively Recruiting
20
Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021
Hackensack, New Jersey, United States, 07601
Actively Recruiting
21
San Juan Oncology Associates- Site Number : 8400016
Farmington, New Mexico, United States, 87401
Actively Recruiting
22
Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003
New York, New York, United States, 10065
Actively Recruiting
23
Duke University Medical Center- Site Number : 8400018
Durham, North Carolina, United States, 27710
Actively Recruiting
24
Gabrail Cancer Center- Site Number : 8400010
Canton, Ohio, United States, 44718
Actively Recruiting
25
University of Cincinnati Medical Center- Site Number : 8400043
Cincinnati, Ohio, United States, 45219
Actively Recruiting
26
Oncology Hematology Care - Kenwood- Site Number : 8400014
Cincinnati, Ohio, United States, 45236
Actively Recruiting
27
Roper Saint Francis Healthcare- Site Number : 8400013
Charleston, South Carolina, United States, 29401
Actively Recruiting
28
Prisma Health Cancer Institute - Greenville- Site Number : 8400019
Greenville, South Carolina, United States, 29615
Actively Recruiting
29
Gibbs Cancer Center & Research Institute - Spartanburg- Site Number : 8400001
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
30
Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road- Site Number : 8400035
Knoxville, Tennessee, United States, 37909
Actively Recruiting
31
University of Tennessee Medical Center- Site Number : 8400006
Knoxville, Tennessee, United States, 37920
Actively Recruiting
32
Tennessee Oncology Nashville- Site Number : 8400012
Nashville, Tennessee, United States, 37203
Actively Recruiting
33
Northern Virginia Oncology Group- Site Number : 8400045
Fairfax, Virginia, United States, 22031
Actively Recruiting
34
SSM Health Dean Medical Group - Wisconsin - Madison- Site Number : 8400009
Madison, Wisconsin, United States, 53715
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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