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

Multiple myeloma patients get continued access to isatuximab in safety extension study

NCT ID NCT05669989

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study offers continued treatment with isatuximab (a targeted antibody) to adults with multiple myeloma who were already benefiting from it in earlier trials. About 70 participants will receive the drug, possibly combined with other medications, to monitor long-term safety. The goal is to ensure patients can keep accessing a therapy that works for them.

What this could mean

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

Active substance
Isatuximab (with possible cemiplimab, dexamethasone, lenalidomide, or pomalidomide)
What this could lead to
If successful, this study could show that long-term isatuximab treatment is safe and continues to control multiple myeloma, offering ongoing benefit to patients.
What could go wrong
This is a small, open-label extension study (70 participants) focused on safety, not on proving new effectiveness. It may not show clear long-term benefits or apply to all patients.

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 70 people

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

Started

Apr 2023

Expected to finish

Nov 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: * Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent. * Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximab monotherapy or in a combination regimen with all the study objectives completed. * Participants still receiving isatuximab at the time of the parental study closure, who are continuing to benefit from isatuximab as monotherapy or in combination, as determined by the treating physician, and who meet the criteria to initiate a subsequent cycle of therapy as described in the parental study protocol. A participant not receiving isatuximab at the end of the parental study who does not have access locally to the ongoing treatment may also be included. * Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants. * Capable of giving signed informed consent. Exclusion Criteria: * Participant has evidence of progressive disease during or at the time of the parental study closure. * Participant has not recovered to ≤Grade 2 from nonhematologic AEs (as per NCI CTCAE v5.0) related to any anticancer therapy received prior to signing informed consent on the extension study. * As the latest line of treatment participant received an antimyeloma therapy other than the isatuximab-based therapy in the parental study before the first IMP in this study. * Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized. * 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. * Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals. * Any country-related specific regulation that would prevent the participant from entering the study. 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 Plasma cell 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.

Plasma cell myeloma

How to take part

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

  1. The places running it

    37 sites in 17 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

Locations

  • Hospital Mae de Deus- Site Number : 0760003

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

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - HCFMUSP- Site Number : 0760002

    São Paulo, São Paulo, 05403-010, Brazil

  • Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760001

    Rio de Janeiro, 22775-001, Brazil

  • Investigational Site Number : 0360001

    Saint Leonards, New South Wales, 2065, Australia

  • Investigational Site Number : 0360002

    Richmond, Victoria, 3121, Australia

  • Investigational Site Number : 0360003

    Wollongong, New South Wales, 2500, Australia

  • Investigational Site Number : 0360004

    Melbourne, Victoria, 3065, Australia

  • Investigational Site Number : 0360005

    Melbourne, Victoria, 3084, Australia

  • Investigational Site Number : 0360006

    Blacktown, New South Wales, 2148, Australia

  • Investigational Site Number : 1520001

    Temuco, 4780000, Chile

  • Investigational Site Number : 1560001

    Tianjin, 300020, China

  • Investigational Site Number : 1580001

    Taichung, 404, Taiwan

  • 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 : 2460001

    Helsinki, 00029, Finland

  • Investigational Site Number : 2500002

    Nantes, 44093, France

  • Investigational Site Number : 3000001

    Pátrai, 265 04, Greece

  • Investigational Site Number : 3000003

    Athens, 115 28, Greece

  • Investigational Site Number : 3000004

    Athens, 106 76, Greece

  • Investigational Site Number : 3800002

    Torino, 10126, Italy

  • Investigational Site Number : 3920001

    Okayama, 701-1192, Japan

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 06591, South Korea

  • Investigational Site Number : 5540001

    Wellington, 6021, New Zealand

  • Investigational Site Number : 5540002

    Auckland, 2025, New Zealand

  • Investigational Site Number : 6430001

    Moscow, 125284, Russia

  • Investigational Site Number : 6430002

    Kirov, 610027, Russia

  • Investigational Site Number : 7240001

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240002

    Salamanca, 37007, Spain

  • Investigational Site Number : 7240003

    Madrid, 28041, Spain

  • Investigational Site Number : 7240004

    Santander, Cantabria, 39008, Spain

  • Investigational Site Number : 7240005

    Badalona, Catalunya [Cataluña], 08916, Spain

  • Investigational Site Number : 7240006

    Seville, Andalusia, 41013, Spain

  • Investigational Site Number : 7241001

    Madrid, Madrid, Comunidad de, 28027, Spain

  • Investigational Site Number : 7520004

    Luleå, 971 80, Sweden

  • Washington University- Site Number : 8400001

    St Louis, Missouri, 63110, United States

More trials for these conditions

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