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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 : Active, not recruiting
First Posted : December 2, 2020
Last Update Posted : April 18, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 6, 2020
First Posted Date  ICMJE December 2, 2020
Last Update Posted Date April 18, 2022
Actual Study Start Date  ICMJE February 2, 2021
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2020)
objective response rate [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
objective response rate (IMWG response criteria)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2021)
  • duration of response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    duration of response (IMWG response criteria)
  • complete response rate [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    complete response rate (IMWG response criteria)
  • duration of complete response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    duration of complete response (IMWG response criteria)
  • progression free survival [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    progression free survival (IMWG response criteria)
  • time to response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    time to response (IMWG response criteria)
  • 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)
  • frequency of treatment-emergent adverse events [ Time Frame: up to approximately 2 years ]
    type and severity (including severity per NCI CTCAE v5)
  • 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)
  • concentrations of elranatamab (PF-06863135) [ Time Frame: assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] ]
    pharmacokinetics of elranatamab
  • 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)
  • overall survival [ Time Frame: at least approximately 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2020)
  • duration of response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    duration of response (IMWG response criteria)
  • cumulative complete response rate [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    cumulative complete response rate (IMWG response criteria)
  • 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)
  • progression free survival [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    progression free survival (IMWG response criteria)
  • time to response [ Time Frame: assessed approximately every 4 weeks [up to approximately 2 years] ]
    time to response (IMWG response criteria)
  • 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)
  • frequency of treatment-emergent adverse events [ Time Frame: up to approximately 2 years ]
    type and severity (including severity per NCI CTCAE v5)
  • 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)
  • concentrations of PF-06863135 [ Time Frame: assessed approximately every 1 to 3 cycles [each cycle approximately 28 days] ]
    pharmacokinetics of PF-06863135
  • 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)
  • overall survival [ Time Frame: up to approximately 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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
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.
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: Elranatamab (PF-06863135)
BCMA-CD3 bispecific antibody
Study Arms  ICMJE
  • Experimental: Elranatamab (cohort A)
    BCMA-CD3 bispecific antibody
    Intervention: Drug: Elranatamab (PF-06863135)
  • Experimental: Elranatamab (cohort B)
    BCMA-CD3 bispecific antibody
    Intervention: Drug: Elranatamab (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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2021)
180
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2020)
150
Estimated Study Completion Date  ICMJE January 9, 2024
Estimated Primary Completion Date July 1, 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
  • 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)
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Japan,   Poland,   Spain,   United Kingdom,   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: Alias Study Number )
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2022

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