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Promising combo slows myeloma progression in Late-Stage trial

NCT ID NCT03275285

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether adding the drug isatuximab to a standard two-drug regimen (carfilzomib and dexamethasone) helps people with multiple myeloma that has returned or stopped responding to prior treatments. 302 adults who had already received 1 to 3 prior therapies took part. The main goal was to see if the three-drug combination delayed cancer growth longer than the two-drug regimen alone.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

302 people

The number who actually took part.

Started

Oct 2017

Finished

Jan 2025

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 with MM previously treated with prior 1 to 3 lines and with measurable serum M-protein (\>= 0.5 gram/deciliter) and/or urine M-protein (\>= 200 milligram/24 hours). Exclusion criteria: * Participants previously pretreated with carfilzomib, who never achieved at least one minor response during previous therapies and/or last previous therapy completed within 14 last days. * Participants with serum free light chain (FLC) measurable disease only. * Participants less than 18 years old, participants with Eastern Cooperative Oncology Group performance status more than 2. * Participants with inadequate biological tests. * Participants with myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association class III or IV congestive heart failure, superior or equal to grade 3 arrhythmias, stroke or transient ischemic attack within last 6 months, and/or left ventricular ejection fraction lower than 40%. * Participants with previous cancer unless disease free for more than 5 years or in situ cancer curatively treated. * Participants with known acquired immunodeficiency syndrome related illness or human immunodeficiency virus requiring antiretroviral treatment, or hepatitis A, B, or C active infection. * Women of childbearing potential or male participant with women of childbearing potential who do not agree to use highly effective method of birth control. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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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

Contacts and locations

Locations

  • Hospital Mae de Deus Site Number : 0760003

    Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

  • Hospital Sao Rafael - Rede D'OR Sao Luiz Site Number : 0760005

    Salvador, Estado de Bahia, 41253-900, Brazil

  • Hospital das Clinicas de Sao Paulo Site Number : 0760002

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital de Amor - Hospital do Cancer de Barretos - Fundacao Pio XII Site Number : 0760001

    Barretos, São Paulo, 14784-400, Brazil

  • Instituto COI de Educacao e Pesquisa Site Number : 0760004

    Rio de Janeiro, 22775-002, Brazil

  • Investigational Site Number : 0360001

    Fitzroy, Victoria, 3065, Australia

  • Investigational Site Number : 0360002

    Wollongong, New South Wales, 2500, Australia

  • Investigational Site Number : 0360004

    Heidelberg West, Victoria, 3081, Australia

  • Investigational Site Number : 0360005

    Blacktown, New South Wales, 2148, Australia

  • Investigational Site Number : 0360006

    Tweed Heads, New South Wales, 2485, Australia

  • Investigational Site Number : 0360007

    Nedlands, Western Australia, 6009, Australia

  • Investigational Site Number : 0360008

    West Perth, Western Australia, 6005, Australia

  • Investigational Site Number : 1240001

    Saint John, New Brunswick, E2L 4L2, Canada

  • Investigational Site Number : 1240002

    Montreal, Quebec, H1T 2M4, Canada

  • Investigational Site Number : 1240003

    Surrey, British Columbia, V3V 1Z2, Canada

  • Investigational Site Number : 2030001

    Prague, 12808, Czechia

  • Investigational Site Number : 2030002

    Brno, 62500, Czechia

  • Investigational Site Number : 2030003

    Ostrava - Poruba, 70852, Czechia

  • Investigational Site Number : 2030004

    Olomouc, 77900, Czechia

  • Investigational Site Number : 2500001

    Nantes, 44093, France

  • Investigational Site Number : 2500002

    Pessac, 33600, France

  • Investigational Site Number : 2500003

    Lille, 59037, France

  • Investigational Site Number : 2500004

    Poitiers, 86021, France

  • Investigational Site Number : 2500005

    Pierre-Bénite, 69495, France

  • Investigational Site Number : 2500006

    Paris, 75012, France

  • Investigational Site Number : 3000001

    Athens, 11528, Greece

  • Investigational Site Number : 3000002

    Athens, 10676, Greece

  • Investigational Site Number : 3000003

    Thessaloniki, 57010, Greece

  • Investigational Site Number : 3000004

    Pátrai, 26504, Greece

  • Investigational Site Number : 3000005

    Athens, 11527, Greece

  • Investigational Site Number : 3480001

    Budapest, 1097, Hungary

  • Investigational Site Number : 3480003

    Budapest, 1083, Hungary

  • Investigational Site Number : 3480004

    Budapest, 1125, Hungary

  • Investigational Site Number : 3480005

    Kaposvár, 7400, Hungary

  • Investigational Site Number : 3800001

    Pisa, 56126, Italy

  • Investigational Site Number : 3800002

    Torino, 10126, Italy

  • Investigational Site Number : 3800003

    Bologna, 40138, Italy

  • Investigational Site Number : 3800004

    Reggio Emilia, 42123, Italy

  • Investigational Site Number : 3920001

    Suwa-shi, Nagano, 392-8510, Japan

  • Investigational Site Number : 3920002

    Yamagata, 990-9585, Japan

  • Investigational Site Number : 3920003

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Investigational Site Number : 3920004

    Shibuya-ku, Tokyo, 150-8935, Japan

  • Investigational Site Number : 3920005

    Shiwa-gun, Iwate, 028-3695, Japan

  • Investigational Site Number : 3920006

    Shinjuku-ku, Tokyo, 162-8666, Japan

  • Investigational Site Number : 3920007

    Kumamoto, Kumamoto, 860-8556, Japan

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100002

    Gangnam-gu, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi, 03722, South Korea

  • Investigational Site Number : 4100005

    Seoul, 06591, South Korea

  • Investigational Site Number : 4100006

    Busan, Busan, 602-715, South Korea

  • Investigational Site Number : 5540001

    Auckland, 1640, New Zealand

  • Investigational Site Number : 5540002

    Wellington, 6021, New Zealand

  • Investigational Site Number : 6430002

    Yekaterinburg, 620102, Russia

  • Investigational Site Number : 6430003

    Kirov, 610027, Russia

  • Investigational Site Number : 6430004

    Novosibirsk, 630047, Russia

  • Investigational Site Number : 7240001

    Badalona, Catalunya [Cataluña], 08916, Spain

  • Investigational Site Number : 7240002

    Valencia, Valenciana, Comunidad, 46017, Spain

  • Investigational Site Number : 7240003

    Madrid, 28041, Spain

  • Investigational Site Number : 7240004

    Seville, 41013, Spain

  • Investigational Site Number : 7240005

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Investigational Site Number : 7920001

    Ankara, 06500, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Istanbul, 34381, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Adana, 01250, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Samsun, 55139, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Bursa, 16059, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    Bristol, Somerset, BS2 8ED, United Kingdom

  • Investigational Site Number : 8260004

    Plymouth, Devon, PL6 8DH, United Kingdom

  • Investigational Site Number : 8260005

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • Spartanburg Medical Center Site Number : 8400003

    Spartanburg, South Carolina, 29303-3040, United States

  • UCSF MS Center Site Number : 8400002

    San Francisco, California, 94117, United States

More trials for these conditions

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