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NCT07320326

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

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Multi-center, Ambispective, Non-interventional, Observational, Registry Study of the Effectiveness of Elranatamab in Patients With Triple-class Exposed Relapsed/Refractory Multiple Myeloma in Routine Clinical Practice in China(ASPIRE: A Registry Study Of Chinese Patients With TCE-RRMM Treated By Elranatamab)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

159

Start Date

2025-12-30

Completion Date

2028-09-18

Last Updated

2026-01-06

Healthy Volunteers

Conditions

TCE-RRMM

Interventions

DRUG

Elranatamab

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.

Inclusion Criteria: Participants with TCE-RRMM who have received or are planning to start Elranatamab treatment according to the local Health Authority approved product label (routine-care). Patients must meet the following criteria to be eligible for inclusion in the study: In the retrospective part: 1. Male or female patients above 18 years old 2. Patients diagnosed with RRMM(IMWG) 3. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory drug and anti-CD38 monoclonal antibody in any order during the course of treatment 4. Patients received at least 1 treatment dose of Elranatamab treatment after commercial launch in China and according to the approved product label (routine-care) in China (consistent with the approved label in China)\* 5. Patients understand and voluntarily sign an ICF . In the prospective part: 1. Male or female patients above 18 years old 2. Patients diagnosed with RRMM (IMWG) 3. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory drug and anti-CD38 monoclonal antibody in any order during the course of treatment 4. Patients treated with elranatamab as monotherapy or a part of combination therapy and according to the approved product label (routine-care) in China (consistent with the approved label in China)\* 5. Patient understand and voluntarily sign an ICF. \*Note: If patients received Elranatamab treatment at a Hong Kong site,the treatment must consist the indications approved in Hong Kong. Exclusion Criteria: Patients meeting the following criteria will not be included in the study: In the retrospective part: 1. Patients with documented diagnosis of other cancers prior to the diagnosis of MM 2. Patients enrolled in interventional clinical trials of any drug for MM treatment 3. Patients with incomplete medical records or missing clinical laboratory data that preclude effectiveness evaluation. 4. Patients who, in the opinion of the investigator, have other factors that make them unsuitable for study participation. In the prospective part: 1. Patients with documented diagnosis of other cancers prior to the diagnosis of MM 2. Patients with contraindication listed in the package insert of elranatamab 3. Patients enrolled in interventional clinical trials of Elranatamab or any other drug for MM treatment

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China