TCE-RRMMASPIRENCT07320326
ASPIRE: A Registry Study Of Chinese Patients With TCE-RRMM Treated By Elranatamab
An observational study of TCE-RRMM, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TCE-RRMM
- What is being tested?
- Elranatamab
- How many people
- 159 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2025to 18 Sep 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: 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.
Read the 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
- Being tested
- Elranatamab
- Keywords
- TCE-RRMM, Elranatamab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElranatamabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Elranatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Overall Response Rate (ORR):(including PR, VGPR, CR, and sCR)
Measured: 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
Progression-freesurvival
Measured: 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
Overall survival
Measured: As the time from the date of first dose until death due to any cause, assessed up to 27 months.
DOR
Duration of response
Measured: 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
Minimal Residual Disease negativity rate
Measured: 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 to response
Measured: 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
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)
Measured: From the screening visit to the last follow up visit, assessed up to 27 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start30 Dec 2025 (estimated)
- Primary completion18 Jul 2028 (estimated)
- Study completion18 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for TCE-RRMMStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 159 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Jin Lu, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320326
- Sponsor's protocol ID
- ID#98552787
- Acronym
- ASPIRE
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Unplanned
Publications
Kumar et al, 2016
Cocks 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.
PubMed 17574838Osoba 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.
PubMed 9161109Aaronson 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.
PubMed 8433390Kumar 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.
PubMed 27511158Prince 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).
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.
PubMed 39055646Lesokhin 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.
PubMed 37582952Tacchetti 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.
PubMed 39001399Holstein 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.
PubMed 37471687Sanchez 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.
PubMed 33796236Cornelis 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.
PubMed 34303157Gandhi 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.
PubMed 30858549Mateos 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.
PubMed 35332278Puertas 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.
PubMed 38717869
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07320326
- Acronym / sponsor ID
- ASPIRE / ID#98552787
- Conditions
- TCE-RRMM
- Keywords
- TCE-RRMM, Elranatamab
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 18 Jul 2028 (estimated)
- Study completion
- 18 Sep 2028 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elranatamab treatment cohort | – | Drug: ElranatamabIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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).
- 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)*
Key exclusion criteria (10 listed)
- 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.
- Patients with documented diagnosis of other cancers prior to the diagnosis of MM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElranatamabIn 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 treatment cohort |
Primary outcome
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)
6 secondary outcomes
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.
OS
Time frame: 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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Results publicationKumar et al, 2016
- Results publication: PubMed 17574838Cocks 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.
- Results publication: PubMed 9161109Osoba 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.
- Results publication: PubMed 8433390Aaronson 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.
- Results publication: PubMed 27511158Kumar 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.
- Results publicationPrince 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).
- Results publication: PubMed 39055646Tomasson 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.
- Results publication: PubMed 37582952Lesokhin 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.
- Results publication: PubMed 39001399Tacchetti 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.
- Results publication: PubMed 37471687Holstein 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.
- Results publication: PubMed 33796236Sanchez 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.
- Results publication: PubMed 34303157Cornelis 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.
- World Health Organization. Globocan 2022: Multiple Myeloma. Available from: https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf \[\[Last accessed: March 2025\]\]Link provided by the sponsor.
- Individual participant dataSharing planned: No. Unplanned
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TCE-RRMM, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Liu (86-13716926210, pkuphliuyang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07320326, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.