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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04649359
Recruitment Status : Active, not recruiting
First Posted : December 2, 2020
Last Update Posted : April 6, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Elranatamab (PF-06863135) Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MAGNETISMM-3 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
Actual Study Start Date : February 2, 2021
Actual Primary Completion Date : June 17, 2022
Estimated Study Completion Date : January 9, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Elranatamab (cohort A)
BCMA-CD3 bispecific antibody
 Drug: Elranatamab (PF-06863135)
BCMA-CD3 bispecific antibody
Experimental: Elranatamab (cohort B)
BCMA-CD3 bispecific antibody
 Drug: Elranatamab (PF-06863135)
BCMA-CD3 bispecific antibody


Outcome Measures
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Primary Outcome Measures :
  1. objective response rate [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    objective response rate (IMWG response criteria)


Secondary Outcome Measures :
  1. objective response rate by baseline extramedullary disease status [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    objective response rate (IMWG response criteria) by baseline extramedullary disease status (cohort A)

  2. duration of response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    duration of response (IMWG response criteria)

  3. complete response rate [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    complete response rate (IMWG response criteria)

  4. duration of complete response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    duration of complete response (IMWG response criteria)

  5. progression free survival [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    progression free survival (IMWG response criteria)

  6. time to response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    time to response (IMWG response criteria)

  7. minimal residual disease negativity rate [ Time Frame: assessed approximately every 12 months [up to approximately 2 years] ]
    minimal residual disease negativity rate (IMWG response criteria)

  8. frequency of treatment-emergent adverse events [ Time Frame: up to approximately 2 years ]
    type and severity (including severity per NCI CTCAE v5)

  9. frequency of laboratory abnormalities [ Time Frame: assessed at least approximately every cycle [each cycle approximately 28 days] ]
    complete blood count and serum chemistry; type and severity of abnormalities (severity per NCI CTCAE v5)

  10. concentrations of elranatamab (PF-06863135) [ Time Frame: assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] ]
    pharmacokinetics of elranatamab

  11. immunogenicity of elranatamab (PF-06863135) [ Time Frame: assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] ]
    immunogenicity of elranatamab (anti-drug antibodies against elranatamab)

  12. overall survival [ Time Frame: at least approximately 2 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Cohort A: has not received prior BCMA-directed therapy
  • Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)
  • 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
  • POEMS syndrome
  • Stem cell transplant within 12 weeks prior to enrollment
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04649359


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04649359    
Other Study ID Numbers: C1071003
2020-004533-21 ( EudraCT Number )
MagnetisMM-3 ( Other Identifier: Alias Study Number )
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: April 6, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Myeloma
Multiple Myeloma
relapsed Multiple Myeloma
refractory Multiple Myeloma
PF-06863135
BCMA
 bispecific
bispecific antibody
BCMA-CD3 bispecific
Elranatamab
MagnetisMM-3
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
 Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases