Multiple MyelomaNCT05932290

A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma

An observational study of Multiple Myeloma, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 weeks and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Elranatamab
How many people: 514 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2023to 12 Jul 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 weeks and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients treated with elranatamab will come from the MagnetisMM-3 trial. Patients treated with the standard-of-care therapies will come from real-world data sources.

Who may be able to join

Aged 18 years and older at index date
Diagnosis of MM
Measurable disease according to IMWG criteria
ECOG performance status ≤2
Refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-CD38 treatment (ie, triple-class refractory [TCR])
At least 1 treatment following their TCR eligibility

Who cannot join

Acute plasma cell leukemia
Amyloidosis
Smoldering MM
Stem cell transplant within 12 weeks of index or active graft versus host disease (GVHD)
Active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ
Administration with an investigational drug within 30 days prior to index

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer
New York, New York, 10001

Other trials in United States

About this study

Official title: Comparative Effectiveness of Elranatamab (PF-06863135) in Clinical Study C1071003 Versus Standard of Care (SOC) in Real-World (RW) External Control Arms in Patients With Triple-Class Refractory (TCR) Multiple Myeloma (MM)

This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). This study medicine will be compared with standard-of-care (SOC) therapies used in real-world clinical practice. For people receiving elranatamab, the investigators will use data from the phase 2 clinical trial (MagnetisMM-3). The investigators will also use data from multiple real-world sources, representing the SOC in clinical practice. This study does not seek any participants for enrollment. The investigators will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help the investigators to know how well elranatamab can be used for RRMM treatment.

Conditions: Multiple Myeloma
Being tested: Elranatamab, Standard of care
Keywords: Myeloma, Multiple Myeloma, relapsed Multiple Myeloma, refractory Multiple Myeloma, PF-06863135, BCMA, bispecific, bispecific antibody, BCMA-CD3 bispecific, Elranatamab, MagnetisMM-3
Medical subject headings: Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ElranatamabDrug
BCMA-CD3 bispecific antibody
Standard of careDrug
Standard of care

Study groups in NCT05932290
Study group	Role	What they receive
Elranatamab		Patients treated with elranatamab from the MagnetisMM-3 trial Receives: Drug: Elranatamab
Standard of care		Patients treated with standard-of-care therapies from real-world data sources Receives: Drug: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis
PFS: a) C1071003 Cohort A: time from the date of the first dose until confirmed progressive disease (PD) per IMWG criteria or death due to any cause, whichever occurred first; b) RWD COTA: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of >=25% (Percent) from the lowest response value in any 1 or more of the criteria: serum protein electrophoresis (SPEP) with an absolute increase >0.5 gram/deciliter (g/dL); 24-hour(h) urine protein electrophoresis (UPEP) with an absolute increase >200 microgram (mg)/24 h; in participants without measurable serum and urine M-protein, the absolute increase of >10 mg/dL in the difference between involved and uninvolved free light chain (FLC) levels; or an absolute bone marrow plasma cell >10%. Retrospective data was retrieved and observed in the current study for approximately 1.5 months.
Measured: C1071003:First dose to confirmed PD/ death due to any cause or censoring whichever occurred first (maximum of 15 months);COTA:Initiation of first line post TCR MM to PD/ death due to any cause or censoring whichever occurred first (maximum of 64.3 months)
PFS: C1071003 Cohort A Versus COTA Cohort- Using Inverse Probability of Treatment Weights (IPTW)
PFS: a) C1071003 Cohort A: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first; b) COTA: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of >=25% from the lowest response value in any 1 or more of the criteria: SPEP with an absolute increase >0.5 g/dL; 24-hour UPEP with an absolute increase >200 mg/24 h; in participants without measurable serum and urine M-protein, the absolute increase of >10 mg/dL in the difference between involved and uninvolved FLC levels; or an absolute bone marrow plasma cell percentage >10%. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Participants without an event were censored at date of last adequate disease assessment or the data cut-off. Kaplan Meier method was used.
Measured: C1071003:First dose to confirmed PD/ death due to any cause or censoring whichever occurred first (maximum of 15 months);COTA:Initiation of first line post TCR MM to PD/ death due to any cause or censoring whichever occurred first (maximum of 64.3 months)
PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis
PFS: a) C1071003 Cohort A, PFS: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. B) Flatiron Health: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of >= 25% from baseline/nadir value in any one or more of the following: an absolute increase in serum M-protein by SPEP by >= 0.5 g/dL; serum M-protein >= 1 g/dL if the lowest M component was >= 5 g/dL; an absolute increase in urine M-protein by UPEP by >=200 mg/24 h; in participants without measurable serum and urine M-protein levels, an absolute increase in the difference between involved and uninvolved FLC levels of >10 mg/dL. Retrospective data was retrieved and observed in the current study for approximately 1.5 months.
Measured: C1071003:First dose to confirmed PD/death due to any cause or censoring whichever occurred first(maximum of 15 months);Flatiron:Initiation of first line post TCR MM to PD/death due to any cause or censoring,whichever occurred first(maximum of 66.9 months)
PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis
PFS: a) C1071003 Cohort A, PFS: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. B) Flatiron Health: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of >= 25% from baseline/nadir value in any one or more of the following: an absolute increase in serum M-protein by SPEP by >= 0.5 g/dL; serum M-protein >= 1 g/dL if the lowest M component was >= 5 g/dL; an absolute increase in urine M-protein by UPEP by >=200 mg/24 h; in participants without measurable serum and urine M-protein levels, an absolute increase in the difference between involved and uninvolved FLC levels of >10 mg/dL. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Kaplan Meier Method was used for analysis.
Measured: C1071003:First dose to confirmed PD/death due to any cause or censoring whichever occurred first(maximum of 15 months);Flatiron:Initiation of first line post TCR MM to PD/death due to any cause or censoring,whichever occurred first(maximum of 66.9 months)

Secondary outcomes (4)

Overall Survival (OS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; b) COTA Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
Measured: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); COTA: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 64.3 months)
OS: Study C1071003 Cohort A Versus RWD COTA Cohort- Using IPTW Analysis
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; b) COTA Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
Measured: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); COTA: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 64.3 months)
OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; B) Flatiron Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
Measured: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); Flatiron: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 66.9 months)
OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis
OS: a) C1071003 Cohort A: OS was defined as time from the date of the first dose until death due to any cause; B) Flatiron Cohort: OS was defined as time from initiation of the first line after participant identified as having TCR MM until the date of death due to any cause. Kaplan Meier Method was used for analysis. Participants without an event were censored at the latest available record or the data cut-off.
Measured: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); Flatiron: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 66.9 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202312 Jul 2023

First posted6 Jul 2023
Study start1 Jun 2023
Primary completion12 Jul 2023
Study completion12 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies 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: Retrospective
Enrolment: 514 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05932290
Sponsor's protocol ID: C1071031
Status last verified: Oct 2024
First submitted: 14 Jun 2023
Last updated: 29 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
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.

Publications

Costa LJ, LeBlanc TW, Tesch H, Sonneveld P, Kyle RP, Sinyavskaya L, Hlavacek P, Meche A, Ren J, Schepart A, Aydin D, Nador G, DiBonaventura MD. Elranatamab efficacy in MagnetisMM-3 compared with real-world control arms in triple-class refractory multiple myeloma. Future Oncol. 2024;20(17):1175-1189. doi: 10.2217/fon-2023-0995. Epub 2024 Feb 28.
PubMed 38415370

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 2
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Effectiveness of Elranatamab (PF-06863135) in Clinical Study C1071003 Versus Standard of Care (SOC) in Real-World (RW) External Control Arms in Patients With Triple-Class Refractory (TCR) Multiple Myeloma (MM)
ClinicalTrials.gov ID: NCT05932290
Acronym / sponsor ID: C1071031
Conditions: Multiple Myeloma
Keywords: Myeloma, Multiple Myeloma, relapsed Multiple Myeloma, refractory Multiple Myeloma, PF-06863135, BCMA, bispecific, bispecific antibody
Study type: Observational
Recruitment status: Completed
Enrolment: 514 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 1 Jun 2023 (actual)
Primary completion: 12 Jul 2023 (actual)
Study completion: 12 Jul 2023 (actual)
First posted: 6 Jul 2023 (actual)
Results: Posted 29 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Elranatamab	–	Drug: ElranatamabPatients treated with elranatamab from the MagnetisMM-3 trial
Standard of care	–	Drug: Standard of carePatients treated with standard-of-care therapies from real-world data sources

Who may qualify

Ages: 18 weeks and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients treated with elranatamab will come from the MagnetisMM-3 trial. Patients treated with the standard-of-care therapies will come from real-world data sources.

Key inclusion criteria (6 listed)

Aged 18 years and older at index date
Diagnosis of MM
Measurable disease according to IMWG criteria
ECOG performance status ≤2
Refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-CD38 treatment (ie, triple-class refractory [TCR])

Key exclusion criteria (6 listed)

Acute plasma cell leukemia
Amyloidosis
Smoldering MM
Stem cell transplant within 12 weeks of index or active graft versus host disease (GVHD)
Active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ

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
ElranatamabBCMA-CD3 bispecific antibody	Drug	Elranatamab
Standard of careStandard of care	Drug	Standard of care

Primary outcome

Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis
Time frame: C1071003:First dose to confirmed PD/ death due to any cause or censoring whichever occurred first (maximum of 15 months);COTA:Initiation of first line post TCR MM to PD/ death due to any cause or censoring whichever occurred first (maximum of 64.3 months)
PFS: a) C1071003 Cohort A: time from the date of the first dose until confirmed progressive disease (PD) per IMWG criteria or death due to any cause, whichever occurred first; b) RWD COTA: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of >=25% (Percent) from the lowest response value in any 1 or more of the criteria: serum protein electrophoresis (SPEP) with an absolute increase >0.5 gram/deciliter (g/dL); 24-hour(h) urine protein electrophoresis (UPEP) with an absolute increase >200 microgram (mg)/24 h; in participants without measurable serum and urine M-protein, the absolute increase of >10 mg/dL in the difference between involved and uninvolved free light chain (FLC) levels; or an absolute bone marrow plasma cell >10%. Retrospective data was retrieved and observed in the current study for approximately 1.5 months.
PFS: C1071003 Cohort A Versus COTA Cohort- Using Inverse Probability of Treatment Weights (IPTW)
Time frame: C1071003:First dose to confirmed PD/ death due to any cause or censoring whichever occurred first (maximum of 15 months);COTA:Initiation of first line post TCR MM to PD/ death due to any cause or censoring whichever occurred first (maximum of 64.3 months)
PFS: a) C1071003 Cohort A: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first; b) COTA: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of >=25% from the lowest response value in any 1 or more of the criteria: SPEP with an absolute increase >0.5 g/dL; 24-hour UPEP with an absolute increase >200 mg/24 h; in participants without measurable serum and urine M-protein, the absolute increase of >10 mg/dL in the difference between involved and uninvolved FLC levels; or an absolute bone marrow plasma cell percentage >10%. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Participants without an event were censored at date of last adequate disease assessment or the data cut-off. Kaplan Meier method was used.
PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis
Time frame: C1071003:First dose to confirmed PD/death due to any cause or censoring whichever occurred first(maximum of 15 months);Flatiron:Initiation of first line post TCR MM to PD/death due to any cause or censoring,whichever occurred first(maximum of 66.9 months)
PFS: a) C1071003 Cohort A, PFS: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. B) Flatiron Health: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of >= 25% from baseline/nadir value in any one or more of the following: an absolute increase in serum M-protein by SPEP by >= 0.5 g/dL; serum M-protein >= 1 g/dL if the lowest M component was >= 5 g/dL; an absolute increase in urine M-protein by UPEP by >=200 mg/24 h; in participants without measurable serum and urine M-protein levels, an absolute increase in the difference between involved and uninvolved FLC levels of >10 mg/dL. Retrospective data was retrieved and observed in the current study for approximately 1.5 months.
PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis
Time frame: C1071003:First dose to confirmed PD/death due to any cause or censoring whichever occurred first(maximum of 15 months);Flatiron:Initiation of first line post TCR MM to PD/death due to any cause or censoring,whichever occurred first(maximum of 66.9 months)
PFS: a) C1071003 Cohort A, PFS: time from the date of the first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurred first. B) Flatiron Health: time from initiation of the first line after participant identified as having TCR MM to either the date of progression or death due to any cause, whichever occurred first. IMWG criteria for progression: an increase of >= 25% from baseline/nadir value in any one or more of the following: an absolute increase in serum M-protein by SPEP by >= 0.5 g/dL; serum M-protein >= 1 g/dL if the lowest M component was >= 5 g/dL; an absolute increase in urine M-protein by UPEP by >=200 mg/24 h; in participants without measurable serum and urine M-protein levels, an absolute increase in the difference between involved and uninvolved FLC levels of >10 mg/dL. Retrospective data was retrieved and observed in the current study for approximately 1.5 months. Kaplan Meier Method was used for analysis.

4 secondary outcomes

Overall Survival (OS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis
Time frame: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); COTA: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 64.3 months)
OS: Study C1071003 Cohort A Versus RWD COTA Cohort- Using IPTW Analysis
Time frame: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); COTA: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 64.3 months)
OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis
Time frame: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); Flatiron: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 66.9 months)
OS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis
Time frame: C1071003: The date of the first dose until death due to any cause or censoring (maximum up to 15 months); Flatiron: First line after participant identified as having TCR MM until the date of death due to any cause or censoring (maximum of 66.9 months)

Results and safety

Results posted to the registry on 29 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
C1071003 Cohort A	123	123
RWD: COTA	239	239
RWD: Flatiron Health	152	152

Primary outcome: Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis

Time frame: C1071003:First dose to confirmed PD/ death due to any cause or censoring whichever occurred first (maximum of 15 months);COTA:Initiation of first line post TCR MM to PD/ death due to any cause or censoring whichever occurred first (maximum of 64.3 months). Median (95% Confidence Interval). Unit: Months

Measure	C1071003 Cohort A n = 123	RWD: COTA n = 239
Value	NA (NA to NA)	4.70 (3.09 to 5.98)

C1071003 Cohort A vs RWD: COTA: Hazard Ratio (HR): 0.51 (95% CI 0.37 to 0.71), p <.0001, Regression, Cox

Population analysed: Eligible participants whose data was retrieved and was used in this retrospective cohort study. Kaplan Meier method was used for analysis. Participants without an event were censored at the date of last adequate disease assessment or the data cut-off.

Primary outcome: PFS: C1071003 Cohort A Versus COTA Cohort- Using Inverse Probability of Treatment Weights (IPTW)

Measure	C1071003 Cohort A n = 113	RWD: COTA n = 235
Value	NA (NA to NA)	5.26 (3.25 to 6.28)

C1071003 Cohort A vs RWD: COTA: Hazard Ratio (HR): 0.37 (95% CI 0.22 to 0.64), p = .0003, Regression, Cox

Population analysed: Eligible participants whose data was retrieved and was used in this retrospective cohort study. In this outcome measure, IPTW analysis was applied. IPTW eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets, hence "Number of Participants Analyzed" (N) are different from participant flow and baseline section.

Primary outcome: PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using Unweighted Analysis

Time frame: C1071003:First dose to confirmed PD/death due to any cause or censoring whichever occurred first(maximum of 15 months);Flatiron:Initiation of first line post TCR MM to PD/death due to any cause or censoring,whichever occurred first(maximum of 66.9 months). Median (95% Confidence Interval). Unit: Months

Measure	C1071003 Cohort A n = 123	RWD: Flatiron Health n = 152
Value	NA (NA to NA)	3.71 (3.02 to 7.13)

Population analysed: Eligible participants whose data was retrieved and was used in this retrospective cohort study. Kaplan Meier Method was used for analysis. Participants without an event were censored at date of last adequate disease assessment or the data cut-off.

Primary outcome: PFS: Study C1071003 Cohort A Versus Flatiron Cohort - Using IPTW Analysis

Measure	C1071003 Cohort A n = 113	RWD: Flatiron Health n = 150
Value	NA (NA to NA)	2.79 (1.87 to 5.59)

Population analysed: Eligible participants whose data was retrieved and was used in this retrospective cohort study. IPTW analysis: eliminated the effect of confounding by observed baseline participant characteristics, improve covariate balance, and thereby obtained unbiased estimates of treatment effects. IPTW created pseudo-sets and "N" are different from participant and baseline section. Participants without an event were censored at date of last adequate disease assessment or the data cut-off.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality: During observation period of approximately 15 months for C1071003, 64.3 months for RWD: COTA and 66.9 months for RWD: Flatiron Health; Serious adverse events and other adverse events: not applicable as adverse event data was not collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
C1071003 Cohort A	0 of 0	0 of 0	55 of 123
RWD: COTA	0 of 0	0 of 0	171 of 239
RWD: Flatiron Health	0 of 0	0 of 0	90 of 152

Limitations and caveats (from the sponsor): IMWG: International Myeloma Working Group

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38415370Costa LJ, LeBlanc TW, Tesch H, Sonneveld P, Kyle RP, Sinyavskaya L, Hlavacek P, Meche A, Ren J, Schepart A, Aydin D, Nador G, DiBonaventura MD. Elranatamab efficacy in MagnetisMM-3 compared with real-world control arms in triple-class refractory multiple myeloma. Future Oncol. 2024;20(17):1175-1189. doi: 10.2217/fon-2023-0995. Epub 2024 Feb 28.
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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Multiple Myeloma
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Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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

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 Multiple Myeloma, run by Pfizer at 1 site in United States.

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 6 inclusion and 6 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: finished, as of the sponsor's last update on 29 Oct 2024. 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 United States. 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?

Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (PFS): Study C1071003 Cohort A Versus RWD COTA Cohort- Using Unweighted Analysis (time frame: C1071003:First dose to confirmed PD/ death due to any cause or censoring whichever occurred first (maximum of 15 months);COTA:Initiation of first line post TCR MM to PD/ death due to any cause or censoring whichever occurred first (maximum of 64.3 months)). The study lists 4 primary outcomes in all. 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 NCT05932290, which also lists 1 linked publication.

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 29 Oct 2024.