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Multiple MyelomaNCT05565391

A Study to Learn About 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
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Elranatamab
How many people
508 participants
Where
1 siteUnited States
Study dates
3 Oct 2022to 4 Nov 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • 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 electronic health record databases in the United States.

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, we will use data from the phase 2 clinical trial (MagnetisMM-3). We will also use data from two real-world databases, representing the SOC in clinical practice. This study does not seek any participants for enrollment. We will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help us to know how well elranatamab can be used for RRMM treatment.

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 NCT05565391
Study groupRoleWhat they receive
ElranatamabPatients treated with elranatamab from the MagnetisMM-3 trial
Receives: Drug: Elranatamab
Standard of carePatients 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.

  1. Objective Response Rate (ORR)-Unweighted Analysis

    ORR was the percentage of participants with objective response (OR) per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, OR was partial response (PR) or better (stringent complete response [sCR]+complete response [CR]+very good partial response [VGPR]+PR). For Study C1071003 and Flatiron Health, OR was PR or better (at least VGPR+PR). sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& <5% plasma cells in BMA, if measured by sFLC only, preceding criteria + normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum \& urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by >=90% or <200 mg/24h. Clopper-Pearson two-sided 95% exact confidence intervals were estimated.

    Measured: From index date until first documentation of progression, death, or the start of new anticancer therapy (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)

  2. Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using Inverse Probability of Treatment Weights (IPTW) Analysis

    ORR was the percentage of participants with an OR per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, the OR was defined as PR or better (sCR + CR + VGPR + PR). For Study C1071003 and Flatiron Health, OR was defined as PR or better (at least VGPR + PR). sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& <5% plasma cells in BMA, if measured by sFLC only, preceding criteria + normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum \& urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by >=90% or <200 mg/24h. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.

    Measured: From index date until first documentation of progression, death, or the start of new anticancer therapy (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)

  3. Objective Response Rate-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis

    ORR was the percentage of participants with an OR per IMWG criteria. For the analysis set of participants from Study C1071003 and COTA, the OR was defined as PR or better (sCR + CR + VGPR + PR). For Study C1071003 and Flatiron Health, OR was defined as PR or better (at least VGPR + PR). sCR: CR \& normal serum free light chain (sFLC) ratio \& absence of clonal cells in BMB/BMA by IH, IF, or flow cytometry. CR: negative immunofixation on serum \& urine, disappearance of any soft tissue plasmacytoma \& <5% plasma cells in BMA, if measured by sFLC only, preceding criteria + normal sFLC ratio. VGPR: Serum \& urine M-protein detectable by immunofixation but not on electrophoresis; or >=90% reduction in serum \& urine M-protein level <100mg/24h. PR: >=50% reduction in serum M-protein \& reduction in 24h urinary M-protein by >=90% or <200 mg/24h. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.

    Measured: From index date until first documentation of progression, death, or the start of new anticancer therapy (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)

Secondary outcomes (6)

  1. Time to Response (TTR)-Unweighted Analysis

    TTR was defined as the time from the index date to the first documentation of OR. No censoring was performed. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria.

    Measured: From index date to date of first documentation of OR (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)

  2. Time to Response (TTR)-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis

    TTR was defined as the time from the index date to the first documentation of OR. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.

    Measured: From index date to date of first documentation of OR (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)

  3. Time to Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis

    TTR was defined as the time from the index date to the first documentation of OR. OR is defined as having a best overall response (BOR) of confirmed sCR, CR, VGPR or PR per IMWG criteria. Analysis was performed using IPTW method to balance participant characteristics among reporting groups.

    Measured: From index date to date of first documentation of OR (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)

  4. Duration of Response (DOR)-Unweighted Analysis

    DOR was defined as the time from the first documentation of OR, until confirmed disease progression (PD) per IMWG criteria, or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; and urine M-protein [absolute increase >=200mg/24h]).

    Measured: From first documentation of OR until confirmed PD or death due to any cause or censoring date (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)

  5. Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and COTA Cohort Using IPTW Analysis

    DOR was defined as the time from the first documentation of OR, until confirmed disease progression (PD) per IMWG criteria, or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; and urine M-protein [absolute increase >=200mg/24h]). Median and 95% Confidence Interval (CI) reported in the descriptive section was determined using unweighted analysis.

    Measured: From first documentation of OR until confirmed PD or death due to any cause or censoring date (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)

  6. Duration of Response-Comparison Between Elranatamab in Study C1071003 Cohort A and Flatiron Health Cohort Using IPTW Analysis

    DOR was defined as the time from the first documentation of OR, until confirmed disease progression (PD) per IMWG criteria, or death due to any cause, whichever occurred first. PD= increase of >=25% from lowest value in >=1 of following (serum M-protein [absolute increase >=0.5g/dL]; serum M-protein increase >=1g/dL [when lowest M-protein >=5g/dL]; and urine M-protein [absolute increase >=200mg/24h]). Median and 95% Confidence Interval (CI) reported in the descriptive section was determined using unweighted analysis.

    Measured: From first documentation of OR until confirmed PD or death due to any cause or censoring date (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)

Timeline

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

  1. First posted4 Oct 2022
  2. Study start3 Oct 2022
  3. Primary completion4 Nov 2022
  4. Study completion4 Nov 2022

Resources

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
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05565391
Sponsor's protocol ID
C1071024
Status last verified
Apr 2024
First submitted
29 Sep 2022
Last updated
21 May 2024
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.

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 21 May 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 22 Apr 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?

Objective Response Rate (ORR)-Unweighted Analysis (time frame: From index date until first documentation of progression, death, or the start of new anticancer therapy (median follow-up of 10.4 months for study C1071003 cohort A, 8.8 months and 7.7 months for COTA and Flatiron Health cohorts)). The study lists 3 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 NCT05565391.

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 21 May 2024.

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