Refractory Multiple Myeloma (RRMM)NCT07391761
A Real World Study of Elranatamab in Patients With RR Multiple Myeloma in Taiwan
An observational study of Refractory Multiple Myeloma (RRMM), run by Pfizer at 4 sites in Taiwan.
Trial summary
The purpose of this study is to evaluate: What is the real-world effectiveness of elranatamab in patients with relapsed and/or refractory multiple myeloma (RRMM) in Taiwan? What are the baseline and clinical characteristics of RRMM patients who have received eltanatamab in Taiwan? What are the treatment patterns of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Multiple Myeloma (RRMM)
- What is being tested?
- Non intervention
- How many people
- 1 participants
- Where
- 4 sitesTaiwan
- Study dates
- 11 May 2026to 31 Jan 2028
- 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: Study population will consist of RRMM patients who have initiated elranatamab in consistent with the local health authority approved product label
Who may be able to join
- Patients age ≥ 18 years at the initiation of elranatamab
- Patients who have received at least one dose of elranatamab in consistent with the approved label in Taiwan.
- Evidence of a personally signed and dated informed consent document (ICD) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. The ICD waiver is acceptable for patient who was ceased before recruitment.
Who cannot join
- Patients who participated in any prior clinical trials using elranatamab.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Kaohsiung Chang Gung Memorial Hospital
Kachsiung, 833
Taichung Veterans General Hospital
Taichung, 40705
Taipei Veterans General Hospital
Taipei, 11217
Linkou Chang Gung Memorial Hospital
Taoyuan, 333
About this study
Official title: A Multi-center Observational Study of the Effectiveness of Elranatamab in Patients With Relapsed and/or Refractory Multiple Myeloma in Taiwan
The purpose of this study is to evaluate:
- What is the real-world effectiveness of elranatamab in patients with relapsed and/or refractory multiple myeloma (RRMM) in Taiwan?
- What are the baseline and clinical characteristics of RRMM patients who have received eltanatamab in Taiwan?
- What are the treatment patterns of RRMM patients receiving elranatamab in the real-world setting in Taiwan?
Read the detailed description
This study is seeking participants who:
- have relapsed or refractory multiple myeloma (RRMM),
- have received at least four prior lines of therapy (including a PI, an IMiD, and an anti-CD38 antibody),
- are 18 years or older.
Participants receive elranatamab according to the approved label in Taiwan and continue treatment until disease progression or discontinuation. The study will evaluate real-world effectiveness and describe patient characteristics and treatment patterns to better understand elranatamab use in routine care.
- Conditions
- Refractory Multiple Myeloma (RRMM)
- Being tested
- Non intervention
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionDrug
Non intervention
| Study group | Role | What they receive |
|---|---|---|
| Elranatamab in Patients with Relapsed and/or Refractory Multiple Myeloma | Patients with Relapsed and/or Refractory Multiple Myeloma treated with Elranatamab Receives: Drug: Non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
rwTTR (real-world time to response)
Time from index date to the first documented real-world response.
Measured: At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.)
rwORR (real-world overall response rate)
Proportion of patients achieving real-world overall response at predefined assessment time points.
Measured: At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.)
rwDOR (real-world duration of response）
Time from the first documented real-world response to real-world disease progression, death, or end of study.
Measured: From first response until 18 months
rwPFS (real-world progression-free survival)
Time from index date to the first documented real-world disease progression or death.
Measured: From initiation of elranatamab treatment (index date) until 18 months
rwOS (real world overall survival)
Time from index date to death from any cause.
Measured: From initiation of elranatamab treatment (index date) until 18 months
rwTTNT (real world time to next treatment)
Time from index date to initiation of the next line of anti-myeloma therapy or end of study.
Measured: From initiation of elranatamab treatment (index date) until 18 months
Secondary outcomes (10)
Demographic: Age
Age (measured in years)
Measured: At baseline
Demographic: Sex
sex/gender (male/female)
Measured: From MM diagnosis until index date, and from index date until 18 months
Anthropometric Measures
Height (in cm), weight (in kg), BMI (kg/m²),
Measured: At baseline
ECOG Performance Status
Number and proportion of patients in each ECOG PS category (0-5)
Measured: At baseline
Myeloma-related Clinical Characteristics
Baseline disease characteristics including myeloma type (IgG, non-IgG, light-chain, non-secretory), bone marrow plasma cell %, presence of EMD, ECOG status, CRAB symptoms, ISS/R-ISS stage, MGUS, SMM, and cytogenetic risk.
Measured: At baseline
Laboratory Characteristics
Baseline laboratory result of creatinine clearance (CrCl) categories (stages 1-5 or <30/≥30 mL/min)
Measured: At baseline
Prior Treatment History
Number and proportion of patients with prior ASCT, prior anti-MM therapies
Measured: At baseline
Time from Diagnosis and Line of Elranatamab Treatment
Time from MM diagnosis to elranatamab initiation.
Measured: From the index date (initiation of elranatamab treatment) up to 18 months
Elranatamab Discontinuation and Treatment Modifications
Number and proportion of patients with treatment discontinuation (and reasons), dosing or schedule modifications (excluding step-up), and switches from QW to Q2W after 6 cycles.
Measured: From the index date (initiation of elranatamab treatment) up to 18 months
Subsequent Treatments After Progression
Number and proportion of patients receiving subsequent treatments following first progression or discontinuation of elranatamab.
Measured: From the index date (initiation of elranatamab treatment) up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start11 May 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391761
- Sponsor's protocol ID
- C1071049
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Observational Study of the Effectiveness of Elranatamab in Patients With Relapsed and/or Refractory Multiple Myeloma in Taiwan
- ClinicalTrials.gov ID
- NCT07391761
- Acronym / sponsor ID
- C1071049
- Conditions
- Refractory Multiple Myeloma (RRMM)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 6 Feb 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.
The purpose of this study is to evaluate:
- What is the real-world effectiveness of elranatamab in patients with relapsed and/or refractory multiple myeloma (RRMM) in Taiwan?
- What are the baseline and clinical characteristics of RRMM patients who have received eltanatamab in Taiwan?
- What are the treatment patterns of RRMM patients receiving elranatamab in the real-world setting in Taiwan?
Detailed description
This study is seeking participants who:
- have relapsed or refractory multiple myeloma (RRMM),
- have received at least four prior lines of therapy (including a PI, an IMiD, and an anti-CD38 antibody),
- are 18 years or older.
Participants receive elranatamab according to the approved label in Taiwan and continue treatment until disease progression or discontinuation. The study will evaluate real-world effectiveness and describe patient characteristics and treatment patterns to better understand elranatamab use in routine care.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elranatamab in Patients with Relapsed and/or Refractory Multiple Myeloma | – | Drug: Non interventionPatients with Relapsed and/or Refractory Multiple Myeloma treated with Elranatamab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will consist of RRMM patients who have initiated elranatamab in consistent with the local health authority approved product label
Key inclusion criteria (3 listed)
- Patients age ≥ 18 years at the initiation of elranatamab
- Patients who have received at least one dose of elranatamab in consistent with the approved label in Taiwan.
- Evidence of a personally signed and dated informed consent document (ICD) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. The ICD waiver is acceptable for patient who was ceased before recruitment.
Key exclusion criteria (1 listed)
- Patients who participated in any prior clinical trials using elranatamab.
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 |
|---|---|---|
| Non interventionNon intervention | Drug | Elranatamab in Patients with Relapsed and/or Refractory Multiple Myeloma |
Primary outcome
rwTTR (real-world time to response)
Time frame: At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.)
Time from index date to the first documented real-world response.
rwORR (real-world overall response rate)
Time frame: At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.)
Proportion of patients achieving real-world overall response at predefined assessment time points.
rwDOR (real-world duration of response）
Time frame: From first response until 18 months
Time from the first documented real-world response to real-world disease progression, death, or end of study.
rwPFS (real-world progression-free survival)
Time frame: From initiation of elranatamab treatment (index date) until 18 months
Time from index date to the first documented real-world disease progression or death.
rwOS (real world overall survival)
Time frame: From initiation of elranatamab treatment (index date) until 18 months
Time from index date to death from any cause.
rwTTNT (real world time to next treatment)
Time frame: From initiation of elranatamab treatment (index date) until 18 months
Time from index date to initiation of the next line of anti-myeloma therapy or end of study.
10 secondary outcomes
Demographic: Age
Time frame: At baseline
Demographic: Sex
Time frame: From MM diagnosis until index date, and from index date until 18 months
Anthropometric Measures
Time frame: At baseline
ECOG Performance Status
Time frame: At baseline
Myeloma-related Clinical Characteristics
Time frame: At baseline
Laboratory Characteristics
Time frame: At baseline
Prior Treatment History
Time frame: At baseline
Time from Diagnosis and Line of Elranatamab Treatment
Time frame: From the index date (initiation of elranatamab treatment) up to 18 months
Elranatamab Discontinuation and Treatment Modifications
Time frame: From the index date (initiation of elranatamab treatment) up to 18 months
Subsequent Treatments After Progression
Time frame: From the index date (initiation of elranatamab treatment) up to 18 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 1 Jul 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Multiple Myeloma (RRMM), run by Pfizer at 4 sites in Taiwan.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rwTTR (real-world time to response) (time frame: At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.