NCT07320326

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

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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 159 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Multiple myeloma (MM) is a malignancy characterized by the clonal proliferation of terminally differentiated plasma cells within the bone marrow. It is the second most common hematological malignancy, accounting for 10-15% of all hematological cancers. Over the past three to four decades, the incidence of MM has been increasing globally. Similar trends are observed in China, where the incidence of MM has also been rising. According to the GLOBOCAN database, in 2022, there were an estimated 30,300 new cases of MM and 18,662 deaths. The 5-year prevalence rate was approximately 6.0 per 100,000 people in China. Remarkable progress in MM has been achieved in the past two decades. Proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and anti-CD38 monoclonal antibodies (mAbs) are the cornerstone of MM therapeutics. After the incorporation of three class novel agents the clinical outcomes of patients with MM have improved significantly, however, MM remains incurable, as most patients eventually experience relapse/progression. Relapse and progression remain the primary causes of mortality in MM patients. As relapses are common in MM, and patients often receive various drug combinations throughout the course of their disease, providing optimal therapy for patients already exposed to PIs, IMiDs, and anti-CD38 mAbs s (namely triple-class exposed \[TCE\]) and/or refractory to these drugs (triple-class refractory \[TCR\]) presents a significant therapeutic challenge. The LocoMMotion and MAMMOTH studies have highlighted the dismal outcomes of patients with TCE/TCR MM, with response rates of approximately 30% and a complete response (CR) or better (\<1%). Furthermore, the progression-free survival (PFS) and overall survival (OS) for this patient subset are limited, with a median PFS of no longer than 6 months and median OS of less than 1 year. As a result, there is an urgent and increasing unmet need for novel therapies with new targets, mechanisms of action, and treatment strategies to extend the duration and durability of clinical responses, thereby improving survival outcomes for TCE/TCR MM patients. BMCA is a member of the tumor necrosis factor (TNF) receptor superfamily and plays a crucial role in the survival of long-lived bone marrow plasma cells (PCs). Additionally, the overexpression of serum BCMA correlates with disease progression and shorter PFS and OS in patients with MM, making BCMA an ideal therapeutic target. Recently, immunotherapies targeting BCMA have shown promise in the treatment of relapsed or refractory multiple myeloma (RRMM). The chimeric antigen receptor (CAR) T cell and bispecific antibodies (BsABs) targeting BCMA are emerging as a new standard of care in TCE-RRMM population. To date, two bispecific antibodies targeting CD3 on T cells and BCMA on myeloma cells have been approved globally for the treatment of TCE-RRMM patients. Elranatamab, a humanized BCMA-CD3 BsAB was granted accelerated approval by the FDA in August 2023 for the treatment of patients with TCE-RRMM, based on the results of the MagnetisMM-3 (NCT04649359) study. In the MagnetisMM-3 study (Cohort A), elranatamab led to an ORR of 61%, with a median PFS of 17.2 months in TCE-RRMM patients who had received a median of 5 prior lines of therapy. The median duration of response (DOR) was not reached, with a median follow-up of 33.9 months. Elranatamab was approved by the National Medical Products Administration (NMPA) in March 2025 in China. However, real-world data on its use in the Chinese population is currently lacking, and physicians have limited experience administering it outside of clinical trials. Therefore, collecting real-world data on the effectiveness of Elranatamab in Chinese TCE-RRMM patients after its commercially available in China is crucial.

Conditions

• TCE-RRMM

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-30
• Primary completion: 2028-07-18
• Completion: 2028-09-18
• First posted: 2026-01-06
• Last updated: 2026-01-06

Locations

1 site across 1 country: China