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

NCT07320326

Not Yet RecruitingN/A

Sponsor: Peking University People's Hospital

Conditions: TCE-RRMM

Interventions: Elranatamab

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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)

Beijing, Beijing Municipality, China