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Ph III IdecabtageneVicleucel w/Len VSLen Pts w/New DxMultiplMyelom Subopt RespAfter AutolStemCell Tr

Stefan Octavian Ciurea


A Study On:

  • Multiple Myeloma

Status:

  • Open

Eligibility

Adult, Older adult

Official Title

A Randomized, Open-Label, Phase III 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)

Details

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).


Eligibility

You can join if...

-Participants aged 18 or older 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
-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 great or equal to 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 great or equal to Grade 1 for any nonhematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy.

Get in touch with our study team