Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Needle-Free hope: new shot delivery may ease myeloma treatment

NCT ID NCT05704049

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 drug combination (isatuximab, carfilzomib, and dexamethasone) given under the skin to adults whose multiple myeloma has returned or stopped responding to prior treatments. The main goal is to see how well the cancer responds and to compare two ways of giving the shot: by hand or using a wearable device. About 118 participants will be enrolled, and the study is currently active but no longer recruiting.

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

118 people

The number who actually took part.

Started

Apr 2023

Expected to finish

May 2028

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 multiple myeloma (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). * Participant with relapsed and/or refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy. * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP) or agrees to practice complete abstinence or use approved contraception methods. * Male participants agree to practice true abstinence or agree to use approved contraception methods while receiving study treatment, during dose interruptions and at least 5 months following study treatment discontinuation, even if has undergone a successful vasectomy. * Capable of giving signed informed consent. Exclusion Criteria: * 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 \<9 months before first isatuximab administration or randomization as applicable or, b) Intolerant to the anti-CD38 previously received * Prior treatment with 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 * Uncontrolled or active infection with hepatitis A, B, and C virus; known acquired immunodeficiency syndrome (AIDS)-related illness; active primary amyloid light chain (AL) amyloidosis * Any severe acute or chronic medical condition which could impair the ability of the participant to participate in the study or interfere with interpretation of study results (eg, systemic infection unless specific anti-infective therapy is employed) or participant unable to comply with the study procedures. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Relapsed/refractory multiple myeloma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

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

Relapsed/refractory multiple myeloma

Contacts and locations

Locations

  • Clinica São Germano- Site Number : 0760003

    São Paulo, 04537-080, Brazil

  • Hospital Mae de Deus Site Number : 0760002

    Porto Alegre, Rio Grande do Sul, 90880-480, Brazil

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001

    São Paulo, 05403-000, Brazil

  • Investigational Site Number : 0360001

    Melbourne, Victoria, 3065, Australia

  • Investigational Site Number : 0360002

    Wollongong, New South Wales, 2500, Australia

  • Investigational Site Number : 1560001

    Tianjin, 300020, China

  • Investigational Site Number : 1560002

    Guangzhou, 510060, China

  • Investigational Site Number : 1560003

    Wuhan, 430030, China

  • Investigational Site Number : 1560004

    Shenyang, 110004, China

  • Investigational Site Number : 1560005

    Nanchang, 330006, China

  • Investigational Site Number : 1560006

    Changsha, 410013, China

  • Investigational Site Number : 1560007

    Tianjin, 300060, China

  • Investigational Site Number : 2030001

    Prague, 128 08, Czechia

  • Investigational Site Number : 2030002

    Brno, 625 00, Czechia

  • Investigational Site Number : 2030003

    Ostrava, 708 52, Czechia

  • Investigational Site Number : 2030004

    Olomouc, 779 00, Czechia

  • Investigational Site Number : 3000001

    Athens, 106 76, Greece

  • Investigational Site Number : 3000002

    Athens, 115 28, Greece

  • Investigational Site Number : 3920001

    Kashiwa, Chiba, 277-8577, Japan

  • Investigational Site Number : 3920002

    Okayama, 701-1192, Japan

  • Investigational Site Number : 6200001

    Braga, 4710-243, Portugal

  • Investigational Site Number : 6200004

    Lisbon, 1400-038, Portugal

  • Investigational Site Number : 6200005

    Lisbon, 1649-035, Portugal

More trials for these conditions

Other studies related to the condition(s) this trial covers.