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

NCT07320326 | Not Yet Recruiting

• 1 other identifier: ID#98552787
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

TCE-RRMM

Keywords

TCE-RRMM; Elranatamab

Outcome Measures

Primary Outcomes (1)

• ORR

  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 Outcomes (6)

• PFS

  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

  As the time from the date of first dose until death due to any cause, assessed up to 27 months.

• DOR

  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

  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

  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.

Study Arms (1)

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

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.

Elranatamab treatment cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).
• In the retrospective part:
• Male or female patients above 18 years old
• Patients diagnosed with RRMM(IMWG)
• 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
• 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)\*
• Patients understand and voluntarily sign an ICF .
• In the prospective part:
• Male or female patients above 18 years old
• Patients diagnosed with RRMM (IMWG)
• 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
• 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)\*
• 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.

You may not qualify if:

• Patients meeting the following criteria will not be included in the study:
• In the retrospective part:
• Patients with documented diagnosis of other cancers prior to the diagnosis of MM
• Patients enrolled in interventional clinical trials of any drug for MM treatment
• Patients with incomplete medical records or missing clinical laboratory data that preclude effectiveness evaluation.
• Patients who, in the opinion of the investigator, have other factors that make them unsuitable for study participation.
• In the prospective part:
• Patients with documented diagnosis of other cancers prior to the diagnosis of MM
• Patients with contraindication listed in the package insert of elranatamab
• Patients enrolled in interventional clinical trials of Elranatamab or any other drug for MM treatment

Sponsors & Collaborators

• Pfizer: collaborator
• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (19)

• Kumar et al, 2016

  RESULT

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• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

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• Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.

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• Tomasson MH, Iida S, Niesvizky R, Mohty M, Bahlis NJ, Martinez-Lopez J, Koehne G, Rodriguez-Otero P, Miles Prince H, Viqueira A, Leip E, Conte U, Sullivan ST, Lesokhin AM. Long-term survival and safety of elranatamab in patients with relapsed or refractory multiple myeloma: Update from the MagnetisMM-3 study. Hemasphere. 2024 Jul 24;8(7):e136. doi: 10.1002/hem3.136. eCollection 2024 Jul. No abstract available.

  PMID: 39055646 RESULT

• Lesokhin AM, Tomasson MH, Arnulf B, Bahlis NJ, Miles Prince H, Niesvizky R, Rodriotaguez-Otero P, Martinez-Lopez J, Koehne G, Touzeau C, Jethava Y, Quach H, Depaus J, Yokoyama H, Gabayan AE, Stevens DA, Nooka AK, Manier S, Raje N, Iida S, Raab MS, Searle E, Leip E, Sullivan ST, Conte U, Elmeliegy M, Czibere A, Viqueira A, Mohty M. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results. Nat Med. 2023 Sep;29(9):2259-2267. doi: 10.1038/s41591-023-02528-9. Epub 2023 Aug 15.

  PMID: 37582952 RESULT

• Tacchetti P, Barbato S, Mancuso K, Zamagni E, Cavo M. Bispecific Antibodies for the Management of Relapsed/Refractory Multiple Myeloma. Cancers (Basel). 2024 Jun 26;16(13):2337. doi: 10.3390/cancers16132337.

  PMID: 39001399 RESULT

• Holstein SA, Grant SJ, Wildes TM. Chimeric Antigen Receptor T-Cell and Bispecific Antibody Therapy in Multiple Myeloma: Moving Into the Future. J Clin Oncol. 2023 Sep 20;41(27):4416-4429. doi: 10.1200/JCO.23.00512. Epub 2023 Jul 20.

  PMID: 37471687 RESULT

• Sanchez L, Dardac A, Madduri D, Richard S, Richter J. B-cell maturation antigen (BCMA) in multiple myeloma: the new frontier of targeted therapies. Ther Adv Hematol. 2021 Jan 30;12:2040620721989585. doi: 10.1177/2040620721989585. eCollection 2021.

  PMID: 33796236 RESULT

• Cornelis R, Chang HD, Radbruch A. Keeping up with the stress of antibody production: BAFF and APRIL maintain memory plasma cells. Curr Opin Immunol. 2021 Aug;71:97-102. doi: 10.1016/j.coi.2021.06.012. Epub 2021 Jul 22.

  PMID: 34303157 RESULT

• Gandhi UH, Cornell RF, Lakshman A, Gahvari ZJ, McGehee E, Jagosky MH, Gupta R, Varnado W, Fiala MA, Chhabra S, Malek E, Mansour J, Paul B, Barnstead A, Kodali S, Neppalli A, Liedtke M, Narayana S, Godby KN, Kang Y, Kansagra A, Umyarova E, Scott EC, Hari P, Vij R, Usmani SZ, Callander NS, Kumar SK, Costa LJ. Outcomes of patients with multiple myeloma refractory to CD38-targeted monoclonal antibody therapy. Leukemia. 2019 Sep;33(9):2266-2275. doi: 10.1038/s41375-019-0435-7. Epub 2019 Mar 11.

  PMID: 30858549 RESULT

• Mateos MV, Weisel K, De Stefano V, Goldschmidt H, Delforge M, Mohty M, Cavo M, Vij R, Lindsey-Hill J, Dytfeld D, Angelucci E, Perrot A, Benjamin R, van de Donk NWCJ, Ocio EM, Scheid C, Gay F, Roeloffzen W, Rodriguez-Otero P, Broijl A, Potamianou A, Sakabedoyan C, Semerjian M, Keim S, Strulev V, Schecter JM, Vogel M, Wapenaar R, Nesheiwat T, San-Miguel J, Sonneveld P, Einsele H, Moreau P. LocoMMotion: a prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed and/or refractory multiple myeloma. Leukemia. 2022 May;36(5):1371-1376. doi: 10.1038/s41375-022-01531-2. Epub 2022 Mar 24.

  PMID: 35332278 RESULT

• Puertas B, Fernandez-Sanchez A, Alejo E, Rey-Bua B, Martin-Lopez AA, Perez-Lopez E, Lopez-Parra M, Lopez-Corral L, Gutierrez-Gutierrez NC, Garcia-Sanz R, Puig N, Gonzalez-Calle V, Mateos MV. A research center's experience of T-cell-redirecting therapies in triple-class refractory multiple myeloma. Blood Adv. 2024 Jul 9;8(13):3478-3487. doi: 10.1182/bloodadvances.2024012773.

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• Ahmed A, Killeen RB. Relapsed and Refractory Multiple Myeloma. 2023 Jun 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK592405/

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  RESULT

• Dou X, Duan G, Zhong Y, Liu Y, Peng N, Wen L, Qi J, Zhou M, Zhang X, Lu J. The burden of multiple myeloma in China: Trends from 1990 to 2021 and forecasts for 2050. Cancer Lett. 2025 Jan 2;611:217440. doi: 10.1016/j.canlet.2025.217440. Online ahead of print.

  PMID: 39755360 RESULT

• Malard F, Neri P, Bahlis NJ, Terpos E, Moukalled N, Hungria VTM, Manier S, Mohty M. Multiple myeloma. Nat Rev Dis Primers. 2024 Jun 27;10(1):45. doi: 10.1038/s41572-024-00529-7.

  PMID: 38937492 RESULT

Related Links

• World Health Organization. Globocan 2022: Multiple Myeloma. Available from: https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf \[\[Last accessed: March 2025\]\]

Central Study Contacts

Yang Liu

CONTACT

86-13716926210; pkuphliuyang@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 6, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): July 18, 2028
• Study Completion (Estimated): September 18, 2028
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)