ASPIRE: A Registry Study Of Chinese Patients With TCE-RRMM Treated By Elranatamab

Sponsor
Peking University People's Hospital
Study ID
NCT07320326
Status
Not Yet Recruiting

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Conditions

  • TCE-RRMM

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elranatamab — DRUG
    In the retrospective period, Each patient will be followed up until two years after the first dose of Elranatamab treatment, death, or withdrawal of consent, whichever occurs first. Information collection will be performed every month for the first 6 months after the first dose of Elranatamab treatment and then every 3 months for the following 18 months. The prospective period will include a Screening Period and a Treatment Period. Screening Period assessments will be performed within 7 days prior to treatment. During the Treatment Period, each patient will be followed up until two years after the first dose of Elranatamab treatment, death, or withdrawal of consent, whichever occurs first.

Study Details

This registry study will provide valuable evidence to assess and validate its effectiveness in the Chinese MM population, refine clinical application strategies, and support the optimization of BCMA BsAbs use in MM treatment in China.

Key Dates

Start date
Dec 30, 2025
Status verified
Dec 2025
Primary completion
Jul 18, 2028
Completion
Sep 18, 2028

Study Design

Enrollment
159 participants (estimated)

Arms

  • Arm: Elranatamab treatment cohort
    In the retrospective period, Each patient will be followed up until two years after the first dose of Elranatamab treatment, death, or withdrawal of consent, whichever occurs first. Information collection will be performed every month for the first 6 months after the first dose of Elranatamab treatment and then every 3 months for the following 18 months. The prospective period will include a Screening Period and a Treatment Period. Screening Period assessments will be performed within 7 days prior to treatment. During the Treatment Period, each patient will be followed up until two years after the first dose of Elranatamab treatment, death, or withdrawal of consent, whichever occurs first.

Primary Outcome Measure

ORR [ Time Frame: At the time from the date of first dose until the first documentation of PD, death or start of new anticancer therapy, whichever occurs first , assessed up to 27 months. ]

Central Contacts