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

December 21, 2025 updated by: Jin Lu, MD, Peking University People's Hospital

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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 Inclusion Criteria and the Exclusion Criteria to be eligible for inclusion in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Overall Response Rate (ORR):(including PR, VGPR, CR, and sCR)
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: As the time from the date of first dose until PD per IMWG criteria or death due to any cause, whichever occurs first, assessed up to 27 months.
Progression-freesurvival
As the time from the date of first dose until PD per IMWG criteria or death due to any cause, whichever occurs first, assessed up to 27 months.
OS
Time Frame: As the time from the date of first dose until death due to any cause, assessed up to 27 months.
Overall survival
As the time from the date of first dose until death due to any cause, assessed up to 27 months.
DOR
Time Frame: As the time from the first documentation of objective response that is subsequently confirmed, until PD per IMWG criteria, or death due to any cause, whichever occurs first, assessed up to 27 months.
Duration of response
As the time from the first documentation of objective response that is subsequently confirmed, until PD per IMWG criteria, or death due to any cause, whichever occurs first, assessed up to 27 months.
MRD negativity rate
Time Frame: The proportion of participants in the analysis population with negative MRD per IMWG criteria by BMA at any time after first dose, assessed up to 27 months.
Minimal Residual Disease negativity rate
The proportion of participants in the analysis population with negative MRD per IMWG criteria by BMA at any time after first dose, assessed up to 27 months.
TTR
Time Frame: For participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that is subsequently confirmed, assessed up to 27 months.
Time to response
For participants with an objective response per IMWG criteria, as the time from the date of first dose to the first documentation of objective response that is subsequently confirmed, assessed up to 27 months.
PRO: EORTC QLQ-C30、EORTC QLQ-MY20 and EQ-5D-5L will be used in this study
Time Frame: From the screening visit to the last follow up visit, assessed up to 27 months.

To evaluate the patient-reported outcomes of Elranatamab-treated TCE-RRMM patients in China using the following patient-reported outcome (PRO) instruments:

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) European Organization for Research and Treatment of Cancer Multiple Myeloma Questionnaire (EORTC QLQ-MY20) The EuroQol 5-Dimension 5-level (EQ-5D-5L)
From the screening visit to the last follow up visit, assessed up to 27 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 30, 2025

Primary Completion (Estimated)

July 18, 2028

Study Completion (Estimated)

September 18, 2028

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 21, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ID#98552787

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Unplanned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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