Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| TCE-RRMM | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elranatamab | Drug | Elranatamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Elranatamab treatment cohort
- description
- 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.
- interventionNames
- Drug: Elranatamab
Primary outcomes (1)
- measure
- ORR
- timeFrame
- 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.
- description
- Overall Response Rate (ORR):(including PR, VGPR, CR, and sCR)
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (20)
- RESULTKumar et al, 2016
- RESULTCocks K, Cohen D, Wisloff F, Sezer O, Lee S, Hippe E, Gimsing P, Turesson I, Hajek R, Smith A, Graham L, Phillips A, Stead M, Velikova G, Brown J; EORTC Quality of Life Group. An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma. Eur J Cancer. 2007 Jul;43(11):1670-8. doi: 10.1016/j.ejca.2007.04.022. Epub 2007 Jun 15. PMID 17574838
- RESULTOsoba D, Aaronson N, Zee B, Sprangers M, te Velde A. Modification of the EORTC QLQ-C30 (version 2.0) based on content validity and reliability testing in large samples of patients with cancer. The Study Group on Quality of Life of the EORTC and the Symptom Control and Quality of Life Committees of the NCI of Canada Clinical Trials Group. Qual Life Res. 1997 Mar;6(2):103-8. doi: 10.1023/a:1026429831234. PMID 9161109
- RESULTAaronson 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. PMID 8433390
- RESULTKumar 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. PMID 27511158
- RESULTPrince HM, Bahlis NJ,Rodriguez-Otero P, et al. MagnetisMM-3: Long-Term Update and Efficacy and Safety of Less Frequent Dosing of Elranatamab in Patients with Relapsed or Refractory Multiple Myeloma. Poster presentation at ASH 2024(Abstract 4738).