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Plasma Cell Myeloma RefractoryPhase 2SubQSANCT06356571

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

A Phase 2 study testing Isatuximab SC-OBDS, Montelukast and Dexamethasone in people with Plasma Cell Myeloma Refractory, run by Sanofi at 34 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plasma Cell Myeloma Refractory
What is being tested?
Isatuximab SC-OBDS, Montelukast and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
34 sitesUnited States
Study dates
17 Mar 2025to 15 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Maryland Oncology Hematology - Bethesda- Site Number : 8400038

    Bethesda, Maryland, 20817

  • Beth Israel Deaconess Medical Center - Boston- Site Number : 8400005

    Boston, Massachusetts, 02215

  • Gabrail Cancer Center- Site Number : 8400010

    Canton, Ohio, 44718

  • Roper Saint Francis Healthcare- Site Number : 8400013

    Charleston, South Carolina, 29401

  • University of Cincinnati Medical Center- Site Number : 8400043

    Cincinnati, Ohio, 45219

  • Oncology Hematology Care - Kenwood- Site Number : 8400014

    Cincinnati, Ohio, 45236

  • Life Clinical Trials - Coral Springs- Site Number : 8400055

    Coral Springs, Florida, 33071

  • Pontchartrain Cancer Center - Covington- Site Number : 8400046

    Covington, Louisiana, 70433

  • Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036

    Dearborn, Michigan, 48126

  • Duke University Medical Center- Site Number : 8400018

    Durham, North Carolina, 27705

  • Northern Virginia Oncology Group- Site Number : 8400045

    Fairfax, Virginia, 22031

  • San Juan Oncology Associates- Site Number : 8400016

    Farmington, New Mexico, 87401

  • Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031

    Fort Lauderdale, Florida, 33309

  • Prisma Health Cancer Institute - Greenville- Site Number : 8400019

    Greenville, South Carolina, 29615

  • Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021

    Hackensack, New Jersey, 07601

  • Mayo Clinic in Florida- Site Number : 8400002

    Jacksonville, Florida, 32224

  • AMR Clinical Kansas City, Missouri- Site Number : 8400056

    Kansas City, Missouri, 64114

  • Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road- Site Number : 8400035

    Knoxville, Tennessee, 37909

  • University of Tennessee Medical Center- Site Number : 8400006

    Knoxville, Tennessee, 37920

  • The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054

    Lakeland, Florida, 33812

  • Los Angeles Hematology Oncology Medical Group- Site Number : 8400027

    Los Angeles, California, 90017

  • SSM Health Dean Medical Group - Wisconsin - Madison- Site Number : 8400009

    Madison, Wisconsin, 53715

  • D&H Pompano Research Center- Site Number : 8400049

    Margate, Florida, 33063

  • Tennessee Oncology Nashville- Site Number : 8400012

    Nashville, Tennessee, 37203

  • Smilow Cancer Center at Yale-New Haven- Site Number : 8400020

    New Haven, Connecticut, 06511

  • Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003

    New York, New York, 10065

  • Millennium Oncology - Pembroke Pines- Site Number : 8400011

    Pembroke Pines, Florida, 33024

  • Mayo Clinic in Arizona - Phoenix- Site Number : 8400058

    Phoenix, Arizona, 85054

  • BRCR Global- Site Number : 8400008

    Plantation, Florida, 33322

  • Hematology Oncology Consultants - Royal Oak- Site Number : 8400039

    Royal Oak, Michigan, 48073

  • Gibbs Cancer Center & Research Institute - Spartanburg- Site Number : 8400001

    Spartanburg, South Carolina, 29303

  • Washington University- Site Number : 8400007

    St Louis, Missouri, 63110

  • Florida Cancer Specialists - North- Site Number : 8400030

    St. Petersburg, Florida, 33705

  • Private Practice - Dr. James R. Berenson- Site Number : 8400044

    West Hollywood, California, 90069

Other trials in United States

About this study

Official title: 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)

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.

Read the detailed description

The duration of the study for a participant will include a period for screening of up to 28 days, a study treatment period of 12 months (except early discontinuation), the end-of-treatment (EOT) visit about 30 days after the last dose of study treatment, and a study follow-up period until death or the final study cut-off date. 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 EOT visit or before further anti-myeloma therapy initiation, whichever comes first.

Being tested
Isatuximab SC-OBDS, Montelukast, Dexamethasone, Acetaminophen, Diphenhydramine
Keywords
Anti CD38 monoclonal antibody, SARCLISA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Isatuximab SC-OBDSDrug

    Also called SAR650984, Sarclisa

    Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS

  • MontelukastDrug

    Pharmaceutical form:As per local commercial product-Route of administration:Oral

  • DexamethasoneDrug

    Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV

  • AcetaminophenDrug

    Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV

  • DiphenhydramineDrug

    Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV/oral equivalent (for management of infusion reaction)

  • MethylprednisoloneDrug

    Pharmaceutical form:As per local commercial product-Route of administration:IV

  • CarfilzomibDrug

    Pharmaceutical form:As per local commercial product-Route of administration:IV

Study groups in NCT06356571
Study groupRoleWhat they receive
Isatuximab in combination with weekly carfilzomib and dexamethasoneExperimentalParticipants 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.
Receives: Drug: Isatuximab SC-OBDS; Drug: Montelukast; Drug: Dexamethasone; Drug: Acetaminophen; Drug: Diphenhydramine; Drug: Methylprednisolone; Drug: Carfilzomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    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.

    Measured: 6 months after the Last Participant In (LPI) i.e., approximately 32 months

Secondary outcomes (12)

  1. Number of participants with infusion reactions (IRs)

    Measured: From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months

  2. Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable)

    Measured: From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months

  3. Number of participants with injection site reactions (ISRs)

    Measured: From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months

  4. CR or better

    CR or better assessed according to International Myeloma Working Group (IMWG) criteria assessed by investigator. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates, and a normal FLC ratio of 0.26-1.65 is required for FLC disease only. Two consecutive assessments are needed. No known evidence of progressive disease or new bone/soft tissue lesions if radiographic studies were performed.

    Measured: 12 months after the Last Participant In (LPI) i.e., approximately 38 months

  5. VGPR or better

    VGPR or better assessed according to IMWG criteria assessed by investigator. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg/24 h, or ≥90% decrease in the sum of maximal perpendicular diameter compared to baseline in soft tissue plasmacytoma. FLC only: a ≥90% decrease in the difference between involved and uninvolved FLC levels. Two consecutive assessments are needed. No known evidence of progressive disease or new bone/soft tissue lesions if radiographic studies were performed.

    Measured: 12 months after the Last Participant In (LPI) i.e., approximately 38 months

  6. Duration of response (DOR)

    DOR, defined as the time from date of first investigator determined response for achieving PR or better to first documentation of progressive disease (PD) determined by investigator or death, whichever occurred first.

    Measured: 12 months after the Last Participant In (LPI) i.e., approximately 38 months

  7. Time to first response (TT1R)

    TT1R, defined as the time from first isatuximab administration to first investigator-determined response (PR or better) that is subsequently confirmed.

    Measured: 12 months after the Last Participant In (LPI) i.e., approximately 38 months

  8. Time to best response (TTBR)

    TTBR, defined as the time from first isatuximab administration to first occurrence of investigator-determined best response (PR or better) that is subsequently confirmed.

    Measured: 12 months after the Last Participant In (LPI) i.e., approximately 38 months

  9. Patient experience and Satisfaction Questionnaire v2 (PESQ v2)

    The PESQ v2 has been designed to follow up on participant experience and satisfaction regarding the treatment (side effects and recommendation) and the administration method (comfortability, pain, side effects and overall satisfaction). This questionnaire has been developed using industry standard for instrument development and has been debriefed and adapted based on qualitative interviews with oncology patients. The more general treatment expectations instrument (v1) was further adapted and debriefed with patients to assess manual and OBDS subcutaneous delivery (v2). The trial specific version of the PESQ v2 contains of items administered for the duration of treatment. Response options are presented as a 5-point Likert scale ranging from Strongly agree/very satisfied/definitely yes to strongly disagree/very dissatisfied/definitely no.

    Measured: Cycle 3/Day 15 and Cycle 6/Day 15

  10. Positivity titer of anti-drug antibodies (ADA) in a subset of approximately 30 participants

    Blood samples will be collected for assessing the presence of ADA against isatuximab in plasma from approximately 30 participants. Plasma samples will be screened for antibodies binding to isatuximab and the titer of confirmed positive samples will be reported.

    Measured: From Cycle 1 Day 1 to follow-up (90 days from last administration) i.e, approximately up to 15 months (1 cycle = 28 days)

  11. Maximum observed concentration (Cmax) of isatuximab in a subset of approximately 30 participants

    Measured: Multiple timepoints in Cycle 1 (1 cycle = 28 days)

  12. Cumulative area under the curve over the first 4 weeks of isatuximab treatment (AUC4 weeks) in a subset of approximately 30 participants

    Measured: Multiple timepoints in Cycle 1 (1 cycle = 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start17 Mar 2025
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion15 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06356571
Sponsor's protocol ID
LPS18183
Other IDs
U1111-1298-7348
Acronym
SubQSA
Status last verified
Oct 2026
First submitted
5 Apr 2024
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Isatuximab SC-OBDS, Montelukast and Dexamethasone in people with Plasma Cell Myeloma Refractory, run by Sanofi at 34 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: 6 months after the Last Participant In (LPI) i.e., approximately 32 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06356571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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