Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)

JRCT ID: jRCT2041230141

Registered date:26/01/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 18/02/2021
• Target sample size: 72
• Countries of recruitment: Canada,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Elranatamab
Elranatamab is a heterodimeric humanized full-length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
Other Name: Elrexfio

Outcome(s)

Primary Outcome

Incidence of nonserious adverse events (AEs) leading to permanent discontinuation [ Time Frame: A minimum of 90 days after the last dose of study drug ]
Incidence of serious adverse events (SAEs) [ Time Frame: A minimum of 90 days after the last dose of study drug ]

Key inclusion & exclusion criteria

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

Include criteria

Participants must agree to follow the reproductive criteria as outlined in the protocol
Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).

Exclude criteria

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT06057402