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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

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ClinicalTrials.gov Identifier: NCT04649359
Recruitment Status : Recruiting
First Posted : December 2, 2020
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF 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
Estimated Primary Completion Date : June 25, 2022
Estimated Study Completion Date : October 18, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: PF-06863135 (cohort A)
BCMA-CD3 bispecific antibody
Drug: PF-06863135
BCMA-CD3 bispecific antibody

Experimental: PF-06863135 (cohort B)
BCMA-CD3 bispecific antibody
Drug: PF-06863135
BCMA-CD3 bispecific antibody




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

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

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

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

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

  6. 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)

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

  8. 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)

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

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

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


Information from the National Library of Medicine

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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
  • 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)

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


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
Beverly Hills Cancer Center Not yet recruiting
Beverly Hills, California, United States, 90211
United States, Indiana
Indiana Blood and Marrow Transplantation-Administrative Offices Not yet recruiting
Indianapolis, Indiana, United States, 46237
Indiana Blood and Marrow Transplantation-Clinic Not yet recruiting
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Norton Cancer Institute, St. Matthews Campus Recruiting
Louisville, Kentucky, United States, 40207
Norton Women's and Children's Hospital Recruiting
Louisville, Kentucky, United States, 40207
United States, South Carolina
Saint Francis Hospital Cancer Center Not yet recruiting
Greenville, South Carolina, United States, 29607
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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: Pfizer )
First Posted: December 2, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
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