MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb

NCT04649359

Last updated date
Study Location
Ohio State University Hospital East
Columbus, Ohio, 43203, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Multiple Myeloma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)

- Measurable disease, as defined by at least 1 of the following:

1. Serum M-protein >0.5 g/dL by SPEP

2. Urinary M-protein excretion >200 mg/24 hours by UPEP

3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio

- Refractory to at least one IMiD

- Refractory to at least one PI

- Refractory to at least one anti-CD38 antibody

- Relapsed/refractory to last anti-myeloma regimen

- ECOG performance status ≤2

- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

- Not pregnant and willing to use contraception

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Smoldering multiple myeloma


- Active Plasma cell leukemia


- Amyloidosis


- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or
viral infection


- Any other active malignancy within 3 years prior to enrollment, except for adequately
treated basal cell or squamous cell skin cancer, or carcinoma in situ.


- Previous administration with an investigational drug within 30 days or 5 half-lives
preceding the first dose of study intervention used in this study (whichever is
longer)

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Multiple MyelomaMagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb
NCT04649359
  1. Columbus, Ohio
  2. Columbus, Ohio
  3. Columbus, Ohio
  4. Columbus, Ohio
  5. Columbus, Ohio
  6. Greenville, South Carolina
  7. Beverly Hills, California
  8. Miami, Florida
  9. Miami, Florida
  10. Indianapolis, Indiana
  11. Indianapolis, Indiana
  12. Louisville, Kentucky
  13. Louisville, Kentucky
  14. New Orleans, Louisiana
  15. New York, New York
  16. New York, New York
  17. Boiling Springs, South Carolina
  18. Easley, South Carolina
  19. Greenville, South Carolina
  20. Greenville, South Carolina
  21. Greenville, South Carolina
  22. Greer, South Carolina
  23. Seneca, South Carolina
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Multiple MyelomaCombination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma
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  1. Boston, Massachusetts
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ALL GENDERS
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  1. Los Angeles, California
  2. Los Angeles, California
  3. Rancho Mirage, California
  4. Cleveland, Ohio
  5. Marshfield, Wisconsin
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18 Years+
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Multiple MyelomaCP-751,871 Treatment For Patients With Multiple Myeloma
NCT01536145
  1. Phoenix, Arizona
  2. Scottsdale, Arizona
  3. Tampa, Florida
  4. Boston, Massachusetts
  5. Rochester, Minnesota
  6. New York, New York
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb
Official Title  ICMJE AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY
Brief Summary The purpose of the study is to evaluate whether single-agent PF-06863135 can provide clinical benefit in participants with relapsed/refractory multiple myeloma. PF-06863135 is a bispecific antibody: binding of PF-06863135 to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE Drug: PF-06863135
BCMA-CD3 bispecific antibody
Study Arms  ICMJE
  • Experimental: PF-06863135 (cohort A)
    BCMA-CD3 bispecific antibody
    Intervention: Drug: PF-06863135
  • Experimental: PF-06863135 (cohort B)
    BCMA-CD3 bispecific antibody
    Intervention: Drug: PF-06863135
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 24, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 18, 2023
Estimated Primary Completion Date June 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
  • Measurable disease, as defined by at least 1 of the following:

    1. Serum M-protein >0.5 g/dL by SPEP
    2. Urinary M-protein excretion >200 mg/24 hours by UPEP
    3. Serum immunoglobulin FLC?10 mg/dL (?100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
  • Refractory to at least one IMiD
  • Refractory to at least one PI
  • Refractory to at least one anti-CD38 antibody
  • Relapsed/refractory to last anti-myeloma regimen
  • ECOG performance status ?2
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ?1
  • Not pregnant and willing to use contraception

Exclusion Criteria:

  • Smoldering multiple myeloma
  • Active Plasma cell leukemia
  • Amyloidosis
  • Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04649359
Other Study ID Numbers  ICMJE C1071003
2020-004533-21 ( EudraCT Number )
MagnetisMM-3 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description: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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP