A Study to Compare the Efficacy and Safety of Ide-cel with LEN Maintenance Therapy Versus LEN Maintenance Therapy Alone in Adult Participants with NDMM Who Have Suboptimal Response After ASCT

JRCT ID: jRCT2061230084

Registered date:24/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 24/12/2023
• Target sample size: 618
• Countries of recruitment: US,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Canada,Japan,zech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Israel,Japan,Italy,Japan,South Korea,Japan,Norway,Japan,Poland,Japan,Romania,Japan,Spain,Japan,UK,Japan
• Study type: Interventional

Intervention(s)

ArmA
Biological: idecabtagene vicleucel
Specified dose on specified days

Drug: Lenalidomide
Specified dose on specified days

Drug: Fludarabine
Specified dose on specified days

Drug: Cyclophosphamide
Specified dose on specified days

Arm B
Drug: Lenalidomide
Specified dose on specified days

Outcome(s)

• Primary Outcome: Progression Free Survival (PFS)
• Secondary Outcome: Overall Survival (OS)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Cook Mark
• Secondary ID(s): NCT06045806