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Could a simple shot replace IV drips for blood cancer patients?

NCT ID NCT05405166

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Updated 2 times

Summary

This study tests if a shot under the skin works as well as an IV infusion for a multiple myeloma drug combination. About 531 adults with relapsed or hard-to-treat myeloma are taking part. The goal is to see if the shot gives similar cancer-fighting results and is easier for 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 3

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

Participants

531 people

The number who actually took part.

Started

Jun 2022

Expected to finish

Oct 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 with multiple myeloma who have received at least one prior line of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor given alone or in combination. * Measurable serum M-protein (≥ 0.5 g/dL) and/or urine M-protein (≥ 200 mg/24 hours) and/or serum free light chain (FLC) assay (Involved FLC assay ≥10 mg/dL and abnormal serum FLC ratio (\<0.26 or \>1.65)). Exclusion Criteria: * Primary refractory multiple myeloma participants * Participants with prior anti-CD38 treatment: (a) administered less than 9 months before randomization or, (b) intolerant to the anti-CD38 previously received * Prior therapy with pomalidomide * Participants with inadequate biological tests. * Significant cardiac dysfunction * Participants diagnosed or treated for another malignancy within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low risk prostate cancer after curative therapy * Concomitant plasma cell leukemia * Active primary amyloid light -chain amyloidosis * Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment * Know active Hepatitis A infection. Current active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed. * 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 recurrent

Contacts and locations

Locations

  • Atlantic Health System- Site Number : 8400005

    Morristown, New Jersey, 07962, United States

  • Boca Raton Clinical Research Associates- Site Number : 8400030

    Plantation, Florida, 33322, United States

  • CHN - Complexo Hospitalar de Niterói- Site Number : 0760008

    Niterói, Rio de Janeiro, 24020-096, Brazil

  • Clinica São Germano- Site Number : 0760001

    São Paulo, 04537-080, Brazil

  • Gabrail Cancer Center- Site Number : 8400027

    Canton, Ohio, 44718, United States

  • Hattiesburg Clinic- Site Number : 8400006

    Hattiesburg, Mississippi, 39401, United States

  • Hospital Mae de Deus- Site Number : 0760003

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

  • Instituto Americas - Ensino, Pesquisa e Inovação - Rio de Janeiro - Avenida Jorge Curi- Site Number : 0760004

    Rio de Janeiro, 22775-001, Brazil

  • Investigational Site Number : 0320001

    Buenos Aires, 1430, Argentina

  • Investigational Site Number : 0320002

    Buenos Aires, 1181, Argentina

  • Investigational Site Number : 0320003

    Buenos Aires, 1417, Argentina

  • Investigational Site Number : 0320004

    Buenos Aires, 1426, Argentina

  • Investigational Site Number : 0320005

    Buenos Aires, 1431, Argentina

  • Investigational Site Number : 0320006

    La Plata, Buenos Aires, 1900, Argentina

  • Investigational Site Number : 0320007

    Buenos Aires, 1280, Argentina

  • Investigational Site Number : 0320008

    Buenos Aires, 1180, Argentina

  • Investigational Site Number : 0320009

    Mendoza, 5501, Argentina

  • Investigational Site Number : 0320010

    Córdoba, 5000, Argentina

  • Investigational Site Number : 0360001

    Richmond, Victoria, 3121, Australia

  • Investigational Site Number : 0360003

    Wollongong, New South Wales, 2500, Australia

  • Investigational Site Number : 0360004

    Waratah, New South Wales, 2298, Australia

  • Investigational Site Number : 0360006

    Melbourne, Victoria, 3004, Australia

  • Investigational Site Number : 0360007

    Liverpool, New South Wales, 2170, Australia

  • Investigational Site Number : 0360008

    Adelaide, South Australia, 5000, Australia

  • Investigational Site Number : 0360009

    Melbourne, Victoria, 3065, Australia

  • Investigational Site Number : 1240001

    Toronto, Ontario, M5G 2M9, Canada

  • Investigational Site Number : 1240003

    Montreal, Quebec, H1T 2M4, Canada

  • Investigational Site Number : 1240004

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Investigational Site Number : 1520001

    Temuco, La Araucanía, 4780000, Chile

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana de Santiago, 7580206, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 6900941, Chile

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 8380455, Chile

  • Investigational Site Number : 1520005

    Viña del Mar, Valparaiso, 2540364, Chile

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 7620001, Chile

  • Investigational Site Number : 1560001

    Beijing, 100034, China

  • Investigational Site Number : 1560002

    Hangzhou, 310003, China

  • Investigational Site Number : 1560003

    Wuhan, 430022, China

  • Investigational Site Number : 1560004

    Zhengzhou, 450008, China

  • Investigational Site Number : 1560006

    Guangzhou, 510060, China

  • Investigational Site Number : 1560007

    Tianjin, 300020, China

  • Investigational Site Number : 1560008

    Wuhan, 430030, China

  • Investigational Site Number : 1560009

    Tianjin, 300052, China

  • Investigational Site Number : 1560010

    Changsha, 410013, China

  • Investigational Site Number : 1560011

    Qingdao, 266011, China

  • Investigational Site Number : 1560013

    Shenyang, 110004, China

  • Investigational Site Number : 1560018

    Tianjin, 300060, China

  • Investigational Site Number : 1560019

    Nanning, 530021, China

  • Investigational Site Number : 1560020

    Nanchang, 330006, China

  • Investigational Site Number : 1560022

    Beijing, 100191, China

  • Investigational Site Number : 1580001

    Kaohsiung City, 833, Taiwan

  • Investigational Site Number : 1580002

    Taipei, 100, Taiwan

  • Investigational Site Number : 1580005

    Tainan, 704, Taiwan

  • Investigational Site Number : 2030003

    Olomouc, 779 00, Czechia

  • Investigational Site Number : 2030004

    Prague, 128 08, Czechia

  • Investigational Site Number : 2030005

    Brno, 625 00, Czechia

  • Investigational Site Number : 2030006

    Ostrava, 708 52, Czechia

  • Investigational Site Number : 2500001

    Poitiers, 86021, France

  • Investigational Site Number : 2500002

    Nantes, 44093, France

  • Investigational Site Number : 2500003

    Toulouse, 31059, France

  • Investigational Site Number : 2500005

    Paris, 75571, France

  • Investigational Site Number : 2500007

    Tours, 37032, France

  • Investigational Site Number : 2500009

    Saint-Priest-en-Jarez, 42270, France

  • Investigational Site Number : 2760003

    Heidelberg, 69120, Germany

  • Investigational Site Number : 2760005

    Dresden, 01307, Germany

  • Investigational Site Number : 2760006

    Lübeck, 23562, Germany

  • Investigational Site Number : 2760007

    Nuremberg, 90419, Germany

  • Investigational Site Number : 3000001

    Athens, 115 28, Greece

  • Investigational Site Number : 3000002

    Athens, 106 76, Greece

  • Investigational Site Number : 3000003

    Pátrai, 265 04, Greece

  • Investigational Site Number : 3000004

    Thessaloniki, 570 10, Greece

  • Investigational Site Number : 3480002

    Budapest, 1085, Hungary

  • Investigational Site Number : 3480003

    Kaposvár, 7400, Hungary

  • Investigational Site Number : 3480004

    Budapest, 1097, Hungary

  • Investigational Site Number : 3480005

    Székesfehérvár, 8000, Hungary

  • Investigational Site Number : 3480006

    Szombathely, 9700, Hungary

  • Investigational Site Number : 3480008

    Pécs, 7623, Hungary

  • Investigational Site Number : 3800001

    Meldola, Reggio Emilia, 47014, Italy

  • Investigational Site Number : 3800002

    Bologna, 40138, Italy

  • Investigational Site Number : 3800003

    Pavia, 27100, Italy

  • Investigational Site Number : 3800004

    Torette, Ancona, 60020, Italy

  • Investigational Site Number : 3800005

    Brescia, 25123, Italy

  • Investigational Site Number : 3800006

    Rome, Roma, 00168, Italy

  • Investigational Site Number : 3920001

    Nagoya, Aichi-ken, 467-8602, Japan

  • Investigational Site Number : 3920002

    Okayama, Okayama-ken, 701-1192, Japan

  • Investigational Site Number : 3920003

    Kyoto, 603-8151, Japan

  • Investigational Site Number : 3920004

    Tokyo, 150-8935, Japan

  • Investigational Site Number : 3920005

    Higashiibaraki, Ibaraki, 311-3117, Japan

  • Investigational Site Number : 3920007

    Kamogawa, Chiba, 296-8602, Japan

  • Investigational Site Number : 3920009

    Yamagata, 990-9585, Japan

  • Investigational Site Number : 3920010

    Yahaba, Iwate, 028-3695, Japan

  • Investigational Site Number : 3920011

    Osaka, 530-8480, Japan

  • Investigational Site Number : 3920012

    Kamakura, Kanagawa, 247-8533, Japan

  • Investigational Site Number : 5780001

    Oslo, 0450, Norway

  • Investigational Site Number : 5780002

    Ålesund, 6017, Norway

  • Investigational Site Number : 6160001

    Lublin, Lublin Voivodeship, 20-081, Poland

  • Investigational Site Number : 6160004

    Wroclaw, Lower Silesian Voivodeship, 50-088, Poland

  • Investigational Site Number : 6160005

    Krakow, Lesser Poland Voivodeship, 31-501, Poland

  • Investigational Site Number : 7240001

    Pamplona, Navarre, 31008, Spain

  • Investigational Site Number : 7240002

    Salamanca, 37007, Spain

  • Investigational Site Number : 7240003

    Santander, Cantabria, 39008, Spain

  • Investigational Site Number : 7240004

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Investigational Site Number : 7240005

    Madrid, 28034, Spain

  • Investigational Site Number : 7240006

    Murcia, Almería, 30120, Spain

  • Investigational Site Number : 7520001

    Borås, 501 82, Sweden

  • Investigational Site Number : 7520003

    Huddinge, 141 57, Sweden

  • Investigational Site Number : 7920001

    Istanbul, 34381, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Istanbul, 34093, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Izmir, 35100, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Istanbul, 34098, Turkey (Türkiye)

  • Investigational Site Number : 7920007

    Ankara, 06010, Turkey (Türkiye)

  • Investigational Site Number : 7920008

    Istanbul, 34214, Turkey (Türkiye)

  • Investigational Site Number : 7920009

    Ankara, 06200, Turkey (Türkiye)

  • Investigational Site Number : 8260001

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • Investigational Site Number : 8260002

    Leicester, Leicestershire, LE1 5WW, United Kingdom

  • Investigational Site Number : 8260003

    Derby, Derbyshire, DE22 3NE, United Kingdom

  • Investigational Site Number : 8260004

    Birmingham, England, B15 2TH, United Kingdom

  • Investigational Site Number : 8260005

    London, London, City of, W12 0HS, United Kingdom

  • Mayo Clinic in Florida- Site Number : 8400008

    Jacksonville, Florida, 32224, United States

  • MultiHemo - Recife - Rua Padre Carapuceiro- Site Number : 0760007

    Recife, Pernambuco, 51020-280, Brazil

  • New York Oncology Hematology - Albany Cancer Center- Site Number : 8400017

    Albany, New York, 12206, United States

  • Novant Health Neurology & Sleep- Site Number : 8400014

    Charlotte, North Carolina, 28207, United States

  • Núcleo de Oncologia e Hematologia do Ceará- Site Number : 0760006

    Fortaleza, Ceará, 60115-280, Brazil

  • Oncology Hematology Care - Fairfield- Site Number : 8400016

    Fairfield, Ohio, 45014, United States

  • Rocky Mountain Cancer Centers - Aurora- Site Number : 8400021

    Aurora, Colorado, 80012, United States

  • Spartanburg Regional Medical Center- Site Number : 8400002

    Spartanburg, South Carolina, 29303, United States

  • Texas Oncology - San Antonio Medical Center - Research Drive- Site Number : 8400020

    San Antonio, Texas, 78240, United States

  • University of Texas - Southwestern Medical Center- Site Number : 8400024

    Dallas, Texas, 75390, United States

  • Veterans Affairs Medical Center - Salt Lake City- Site Number : 8400011

    Salt Lake City, Utah, 84108, United States