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
- Diseases
- Multiple myeloma
- 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
Sites (108)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SCRI CCCIT Ges.m.b.H. Coordinator of this site? Confirm its status | Salzburg | Austria | Completed |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| - Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Camperdown | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Murdoch | Australia | Unknown status |
| Institut Jules Bordet Coordinator of this site? Confirm its status | Brussels | Belgium | Completed |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Completed |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Completed |
| - Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Completed |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Completed |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Completed |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Completed |
| University Hospital Cologne AöR Coordinator of this site? Confirm its status | Cologne | Germany | Completed |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Completed |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Universitaetsklinikum Heidelberg AöR Coordinator of this site? Confirm its status | Heidelberg | Germany | Completed |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Completed |
| Universitaetsklinikum Leipzig Aor Coordinator of this site? Confirm its status | Leipzig | Germany | Completed |
| Klinikum Nuernberg Coordinator of this site? Confirm its status | Nuremberg | Germany | Completed |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Completed |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Completed |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Completed |
| Catalan Institute of Oncology Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Catalan Institute of Oncology Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| University Clinic of Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Creteil Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Hospital Hotel Dieu Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Active, not recruiting |
| Institut Universitaire Du Cancer Toulouse-Oncopole Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Evaggelismos Hospital Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Completed |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Completed |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Completed |
| - Coordinator of this site? Confirm its status | Beersheba | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Petah Tikva | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospealiero Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| Chiba University Hospital Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Isehara | Japan | Unknown status |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Nagoya City University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Hyogo Medical University Hospital Coordinator of this site? Confirm its status | Nishinomiya | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Japanese Red Cross Medical Center Coordinator of this site? Confirm its status | Shibuya-ku | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Shimotsuke | Japan | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Gliwice | Poland | Active, not recruiting |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Instytut Hematologii I Transfuzjologii Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Fundeni Clinical Institute Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Institutul Regional de Oncologie Iasi Coordinator of this site? Confirm its status | Iași | Romania | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Novant Health Cancer Institute - Elizabeth Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| M Health Fairview Clinics and Surgery Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| AdventHealth Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Ascension Providence Hospital Coordinator of this site? Confirm its status | Southfield | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.