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Wearable device could simplify multiple myeloma treatment

NCT ID NCT06356571

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new method of giving the drug isatuximab (Sarclisa) under the skin using a wearable device, combined with two other drugs (carfilzomib and dexamethasone), in 64 adults with multiple myeloma that has returned or not responded to prior therapy. The main goal is to see how many patients respond to the treatment. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isatuximab (Sarclisa) given under the skin via a wearable device, plus carfilzomib and dexamethasone
What this could lead to
If it works, this could offer a more convenient way to deliver a combination therapy for multiple myeloma that has come back or stopped responding to treatment.
What could go wrong
This is an early-phase (Phase 2) study with only 64 participants, so results may not apply to everyone. Side effects from the drugs or the injection device are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma refractory plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plasma cell myeloma refractory

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    34 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Alliance for Multispeciality Research - Kansas City- Site Number : 8400056

    RECRUITING

    Kansas City, Missouri, 64114, United States

  • BRCR Global- Site Number : 8400008

    RECRUITING

    Plantation, Florida, 33322, United States

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

    RECRUITING

    Boston, Massachusetts, 02215, United States

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

    RECRUITING

    Fort Lauderdale, Florida, 33309, United States

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

    RECRUITING

    Margate, Florida, 33063, United States

  • Duke University Medical Center- Site Number : 8400018

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Florida Cancer Specialists - North- Site Number : 8400030

    RECRUITING

    St. Petersburg, Florida, 33705, United States

  • Gabrail Cancer Center- Site Number : 8400010

    RECRUITING

    Canton, Ohio, 44718, United States

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

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

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

    RECRUITING

    Hackensack, New Jersey, 07601, United States

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

    RECRUITING

    Royal Oak, Michigan, 48073, United States

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

    RECRUITING

    Coral Springs, Florida, 33071, United States

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

    RECRUITING

    Los Angeles, California, 90017, United States

  • Maryland Oncology Hematology- Site Number : 8400038

    RECRUITING

    Washington D.C., District of Columbia, 20017, United States

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

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic in Florida- Site Number : 8400002

    RECRUITING

    Jacksonville, Florida, 32224, United States

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

    RECRUITING

    New York, New York, 10065, United States

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

    RECRUITING

    Dearborn, Michigan, 48126, United States

  • Millennium Oncology - Pembroke Pines- Site Number : 8400011

    RECRUITING

    Pembroke Pines, Florida, 33024, United States

  • Northern Virginia Oncology Group- Site Number : 8400045

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Oncology Hematology Care - Kenwood- Site Number : 8400014

    RECRUITING

    Cincinnati, Ohio, 45236, United States

  • Pontchartrain Cancer Center - Covington- Site Number : 8400046

    RECRUITING

    Covington, Louisiana, 70433, United States

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

    RECRUITING

    Greenville, South Carolina, 29615, United States

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

    RECRUITING

    West Hollywood, California, 90069, United States

  • Roper Saint Francis Healthcare- Site Number : 8400013

    RECRUITING

    Charleston, South Carolina, 29401, United States

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

    RECRUITING

    Madison, Wisconsin, 53715, United States

  • San Juan Oncology Associates- Site Number : 8400016

    RECRUITING

    Farmington, New Mexico, 87401, United States

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

    RECRUITING

    New Haven, Connecticut, 06511, United States

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

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Tennessee Oncology Nashville- Site Number : 8400012

    RECRUITING

    Nashville, Tennessee, 37203, United States

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

    RECRUITING

    Lakeland, Florida, 33812, United States

  • University of Cincinnati Medical Center- Site Number : 8400043

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Tennessee Medical Center- Site Number : 8400006

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • Washington University- Site Number : 8400007

    RECRUITING

    St Louis, Missouri, 63110, United States

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