Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
Celgene (Voir sur ClinicalTrials)
octobre 2023
août 2025
10 septembre 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alina DANU | 23/05/2024 12:57:13 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu - 44000 - Nantes - Pays-de-la-Loire - France | Contact (sur clinicalTrials) | ||||
| Hopital Claude Huriez - CHU de Lille - 59000 - Lille - Nord - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli-Calmettes - 13273 - Marseille - Bouches-du-Rhône - France | Contact (sur clinicalTrials) | ||||
| Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE - 31100 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0028 - 94805 - Villejuif - Val-de-Marne - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0029 - 86021 - Poitiers - Vienne - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0031 - 75571 - Paris - Île-de-France - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0046 - 69310 - Pierre-Bénite - Rhône - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0047 - 33600 - Pessac - Aquitaine - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0082 - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.