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New CAR T-Cell combo aims to stop myeloma in its tracks

NCT ID NCT06045806

Disease control Sponsor: Celgene 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial tests whether adding a CAR T-cell therapy (ide-cel) to standard lenalidomide maintenance can improve outcomes for adults with newly diagnosed multiple myeloma who had a poor response to stem cell transplant. About 79 participants will receive either the combination or lenalidomide alone. The main goal is to see if the combination delays cancer progression.

What this could mean

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

Active substance
idecabtagene vicleucel (CAR T-cell therapy) combined with lenalidomide maintenance
What this could lead to
If successful, this combination could offer a more effective way to control multiple myeloma after stem cell transplant, potentially delaying disease progression and improving survival.
What could go wrong
This is an early-phase 3 trial with only 79 participants, so results may not apply to all patients. CAR T-cell therapy carries risks of serious side effects like cytokine release syndrome and neurological issues.

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

79 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Nov 2029

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 aged ≥18 with Newly Diagnosed Multiple Myeloma (NDMM) who has received induction therapy followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT), without subsequent consolidation or maintenance. EXCEPTION: Participant received ≤ 7 days of lenalidomide (LEN) maintenance therapy and the investigator documents that there is no impact to the overall benefit/risk assessment due to the temporary interruption of LEN. * Participant must have received 4 to 6 cycles of induction therapy, which must contain at a minimum an immunomodulatory drugs (IMiD) and a proteasome inhibitor (PI) (with or without anti-CD38 monoclonal antibody) and must have had a single ASCT 80 to 120 days prior to consent. Note: Participant must not have confirmed progression since commencing induction. * Participant must have documented response of PR or VGPR at time of consent. * Participant must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (participants with ECOG 2 due to pain because of underlying myeloma-associated bone lesions are eligible per investigator's discretion). * Participant must have recovered to ≤ Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy. Exclusion Criteria * Participant with known central nervous system involvement with myeloma. * Participant has non-secretory MM. * Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection. * Participant has history of primary immunodeficiency. * Participant has previous history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene therapy-based therapeutic for cancer or investigational cellular therapy for cancer or B-cell maturation antigen targeted therapy. * Other protocol-defined Inclusion/Exclusion criteria apply.

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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.

Multiple myeloma

Contacts and locations

Locations

  • AdventHealth Orlando

    Orlando, Florida, 32804, United States

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi, 05505, South Korea

  • Ascension Providence Hospital

    Southfield, Michigan, 48075, United States

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, Pays de la Loire Region, 44000, France

  • Chiba University Hospital

    Chiba, 260-8677, Japan

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeonranamdo, 58128, South Korea

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Henri Mondor Hospital

    Créteil, Val-de-Marne, 94010, France

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hopital Claude Huriez - CHU de Lille

    Lille, Nord, 59000, France

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 08036, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hyogo Medical University Hospital

    Nishinomiya, Hyōgo, 663-8501, Japan

  • Institut Paoli-Calmettes

    Marseille, Bouches-du-Rhône, 13273, France

  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

    Toulouse, 31100, France

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo, 150-8935, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Local Institution - 0001

    Hamilton, Ontario, L8V5C2, Canada

  • Local Institution - 0004

    Melbourne, Victoria, 3000, Australia

  • Local Institution - 0005

    Brisbane, Queensland, 4029, Australia

  • Local Institution - 0006

    Melbourne, Victoria, 3004, Australia

  • Local Institution - 0007

    Camperdown, New South Wales, 2050, Australia

  • Local Institution - 0008

    Melbourne, Victoria, 3065, Australia

  • Local Institution - 0011

    Murdoch, Western Australia, 6150, Australia

  • Local Institution - 0012

    Pamplona, Navarre, 31008, Spain

  • Local Institution - 0013

    Salamanca, 37007, Spain

  • Local Institution - 0017

    L'Hospitalet Del Llobregat, Barcelona [Barcelona], 08908, Spain

  • Local Institution - 0020

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Local Institution - 0021

    Madrid, 28041, Spain

  • Local Institution - 0022

    Gliwice, Silesian Voivodeship, 44-101, Poland

  • Local Institution - 0023

    Warsaw, Masovian Voivodeship, 02-776, Poland

  • Local Institution - 0024

    Poznan, 60-569, Poland

  • Local Institution - 0026

    Gdansk, 80-952, Poland

  • Local Institution - 0027

    Lublin, Lublin Voivodeship, 20-090, Poland

  • Local Institution - 0028

    Villejuif, Val-de-Marne, 94805, France

  • Local Institution - 0029

    Poitiers, Vienne, 86021, France

  • Local Institution - 0031

    Paris, Île-de-France Region, 75571, France

  • Local Institution - 0038

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Local Institution - 0043

    Seoul, Seoul Teugbyeolsi, 06591, South Korea

  • Local Institution - 0046

    Pierre-Bénite, Rhône, 69310, France

  • Local Institution - 0047

    Pessac, Aquitaine, 33600, France

  • Local Institution - 0055

    Beersheba, Southern District, 8410101, Israel

  • Local Institution - 0056

    Haifa, 31096, Israel

  • Local Institution - 0057

    Ramat Gan, Central District, 5262100, Israel

  • Local Institution - 0058

    Petah Tikva, Central District, 4910021, Israel

  • Local Institution - 0059

    Jerusalem, 9112001, Israel

  • Local Institution - 0060

    Thessaloniki, Thessaloníki, 570 10, Greece

  • Local Institution - 0061

    Athens, Attikí, 106 76, Greece

  • Local Institution - 0062

    Chaïdári, Attikí, 12462, Greece

  • Local Institution - 0063

    Pátrai, Achaḯa, 26504, Greece

  • Local Institution - 0064

    Rozzano, Milano, 20089, Italy

  • Local Institution - 0065

    Bologna, 40138, Italy

  • Local Institution - 0066

    Roma, 00161, Italy

  • Local Institution - 0069

    Oslo, 0372, Norway

  • Local Institution - 0070

    Odense, Region Syddanmark, 5000, Denmark

  • Local Institution - 0071

    Shimotsuke, 329-0498, Japan

  • Local Institution - 0072

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Local Institution - 0073

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Local Institution - 0074

    Würzburg, 97080, Germany

  • Local Institution - 0076

    Hamburg, 20246, Germany

  • Local Institution - 0077

    Nuremberg, Bavaria, 90419, Germany

  • Local Institution - 0078

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Local Institution - 0079

    Dresden, 01307, Germany

  • Local Institution - 0080

    London, London, City of, SE5 9RS, United Kingdom

  • Local Institution - 0082

    Paris, 75010, France

  • Local Institution - 0083

    Anderlecht, Bruxelles-Capitale, Région de, 1070, Belgium

  • Local Institution - 0084

    Brussels, Bruxelles-Capitale, Région de, 1090, Belgium

  • Local Institution - 0085

    Isehara, Kanagawa, 259-1193, Japan

  • Local Institution - 0087

    Leipzig, Saxony, 04103, Germany

  • Local Institution - 0088

    Tel Aviv, Tell Abīb, 6423906, Israel

  • Local Institution - 0089

    Salzburg, 5020, Austria

  • Local Institution - 0090

    Vienna, 1090, Austria

  • Local Institution - 0091

    Bucharest, 022328, Romania

  • Local Institution - 0093

    Birmingham, England, B15 2TH, United Kingdom

  • Local Institution - 0094

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

  • Local Institution - 0095

    Warsaw, Masovian Voivodeship, 02-097, Poland

  • Local Institution - 0104

    Atlanta, Georgia, 30342, United States

  • Local Institution - 0109

    Houston, Texas, 77030, United States

  • Local Institution - 0113

    Sacramento, California, 95817, United States

  • Local Institution - 0115

    Essen, 45122, Germany

  • Local Institution - 0121

    Atlanta, Georgia, 30322, United States

  • Local Institution - 0124

    Austin, Texas, 78704, United States

  • Local Institution - 0126

    Orange, California, 92868, United States

  • Local Institution - 0131

    Los Angeles, California, 90095, United States

  • Local Institution - 0132

    Philadelphia, Pennsylvania, 19104, United States

  • Local Institution - 0133

    Edmonton, Alberta, T6G 1Z2, Canada

  • Local Institution - 0134

    Montreal, Quebec, H1T 2M4, Canada

  • Local Institution - 0144

    Brussels, Bruxelles-Capitale, Région de, 1200, Belgium

  • Local Institution - 0151

    Boston, Massachusetts, 02215, United States

  • M Health Fairview Clinics and Surgery Center

    Minneapolis, Minnesota, 55455, United States

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602, Japan

  • Novant Health Cancer Institute - Elizabeth

    Charlotte, North Carolina, 28204, United States

  • Okayama University Hospital

    Okayama, 700-8558, Japan

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63108, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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