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NCT06045806Active, not recruitingPhase 3

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (KarMMa-9)

Source: ClinicalTrials.gov · Last updated 5 Mar 2026

Brief summary (registry, in English)

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
79 (actual)
First submitted
13 Sept 2023
Start date
16 Oct 2023
Primary completion date
11 Aug 2025
Lead sponsor
Celgene
NCT number
NCT06045806
EU CT number
2022-501346-30-00
EudraCT number
2022-501346-30

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 79
  • From 16 Oct 2023 to the primary completion date, 11 Aug 2025
  • 108 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 illness

  • Participant has systemic and uncontrolled fungal, bacterial, viral, or other infection.
  • Participant has history of primary immunodeficiency.

Other

  • Participant with known central nervous system involvement with myeloma.
  • Participant has non-secretory MM.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (108)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SCRI CCCIT Ges.m.b.H.
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SalzburgAustriaCompleted
Medical University of Vienna
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ViennaAustriaCompleted
-
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BrisbaneAustraliaUnknown status
-
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CamperdownAustraliaUnknown status
-
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MelbourneAustraliaUnknown status
-
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MelbourneAustraliaUnknown status
-
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MelbourneAustraliaUnknown status
-
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MurdochAustraliaUnknown status
Institut Jules Bordet
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BrusselsBelgiumCompleted
UZ Brussel
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JetteBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
-
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EdmontonCanadaUnknown status
-
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HamiltonCanadaUnknown status
-
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MontrealCanadaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaCompleted
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaCompleted
University Hospital Olomouc
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OlomoucCzechiaCompleted
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaCompleted
University Hospital Cologne AöR
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CologneGermanyCompleted
Technische Universitaet Dresden
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DresdenGermanyCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
University Medical Center Hamburg-Eppendorf
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HamburgGermanyCompleted
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyCompleted
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyCompleted
Universitaetsklinikum Leipzig Aor
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LeipzigGermanyCompleted
Klinikum Nuernberg
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NurembergGermanyCompleted
Universitaetsklinikum Ulm AoR
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UlmGermanyCompleted
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyCompleted
Odense University Hospital
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Odense CDenmarkCompleted
Catalan Institute of Oncology
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Catalan Institute of Oncology
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L'Hospitalet de LlobregatSpainActive, not recruiting
Clinica Universidad de Navarra
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
University Clinic of Navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceActive, not recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
Hospital Hotel Dieu
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NantesFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceActive, not recruiting
Centre Hospitalier Lyon-Sud
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Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceActive, not recruiting
Institut Universitaire Du Cancer Toulouse-Oncopole
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Toulouse Cedex 9FranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
-
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BirminghamUnited KingdomUnknown status
-
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LondonUnited KingdomUnknown status
-
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LondonUnited KingdomUnknown status
Evaggelismos Hospital
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AthensGreeceCompleted
University General Hospital Attikon
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AthensGreeceCompleted
General University Hospital Of Patras
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PatrasGreeceCompleted
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceCompleted
-
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BeershebaIsraelUnknown status
-
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HaifaIsraelUnknown status
-
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JerusalemIsraelUnknown status
-
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Petah TikvaIsraelUnknown status
-
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Ramat GanIsraelUnknown status
-
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Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Istituto Nazionale dei Tumori
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MilanItalyActive, not recruiting
Azienda Ospealiero Universitaria Policlinico Umberto I
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RomeItalyActive, not recruiting
Humanitas Research Hospital
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RozzanoItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
Chiba University Hospital
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ChibaJapanUnknown status
Kyushu University Hospital
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FukuokaJapanUnknown status
-
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IseharaJapanUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
Nagoya City University Hospital
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NagoyaJapanUnknown status
Hyogo Medical University Hospital
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NishinomiyaJapanUnknown status
Okayama University Hospital
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OkayamaJapanUnknown status
Hokkaido University Hospital
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SapporoJapanUnknown status
Japanese Red Cross Medical Center
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Shibuya-kuJapanUnknown status
-
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ShimotsukeJapanUnknown status
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
-
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SeoulSouth KoreaUnknown status
-
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SeoulSouth KoreaUnknown status
Oslo University Hospital HF
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OsloNorwayActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
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GliwicePolandActive, not recruiting
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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LublinPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandActive, not recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandActive, not recruiting
Instytut Hematologii I Transfuzjologii
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WarsawPolandActive, not recruiting
Fundeni Clinical Institute
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BucharestRomaniaActive, not recruiting
Institutul Regional de Oncologie Iasi
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IașiRomaniaActive, not recruiting
-
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AtlantaUnited StatesUnknown status
-
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AtlantaUnited StatesUnknown status
-
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AustinUnited StatesUnknown status
-
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BostonUnited StatesUnknown status
Novant Health Cancer Institute - Elizabeth
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CharlotteUnited StatesUnknown status
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
Colorado Blood Cancer Institute
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DenverUnited StatesUnknown status
-
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HoustonUnited StatesUnknown status
University of Texas - MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
-
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Los AngelesUnited StatesUnknown status
M Health Fairview Clinics and Surgery Center
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MinneapolisUnited StatesUnknown status
Yale University School Of Medicine
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New HavenUnited StatesUnknown status
Columbia University Irving Medical Center
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New YorkUnited StatesUnknown status
-
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OrangeUnited StatesUnknown status
AdventHealth Orlando
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OrlandoUnited StatesUnknown status
-
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PhiladelphiaUnited StatesUnknown status
-
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SacramentoUnited StatesUnknown status
Ascension Providence Hospital
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SouthfieldUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.