NCT06356571 · Sanofi
A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
(SubQSA)
What this study is about
The primary purpose of this study is to assess the effectiveness (overall response rate) of injected under the skin (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.
View original scientific description
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.
Interventions
DRUG
Isatuximab SC-OBDS
Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS
DRUG
Montelukast
Pharmaceutical form:As per local commercial product-Route of administration:Oral
DRUG
Dexamethasone
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
DRUG
Acetaminophen
Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV
DRUG
Diphenhydramine
Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)
DRUG
Methylprednisolone
Pharmaceutical form:As per local commercial product-Route of administration:IV
DRUG
Carfilzomib
Pharmaceutical form:As per local commercial product-Route of administration:IV
Primary outcome measures
Overall response rate (ORR)
Time frame: 6 months after the Last Participant In (LPI) i.e., approximately 32 months
ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to IMWG criteria assessed by investigator.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 und
Where
- Phoenix, Arizona
- Los Angeles, California
- West Hollywood, California
- New Haven, Connecticut
- Washington D.C., District of Columbia
- Coral Springs, Florida
- Fort Lauderdale, Florida
- Jacksonville, Florida
- Lakeland, Florida
- Margate, Florida
- Pembroke Pines, Florida
- Plantation, Florida
And 20 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations