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MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (MAGNETISMM-5)

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ClinicalTrials.gov Identifier: NCT05020236
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : March 12, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 11, 2021
First Posted Date  ICMJE August 25, 2021
Last Update Posted Date March 12, 2024
Actual Study Start Date  ICMJE October 4, 2021
Estimated Primary Completion Date December 27, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2023)
  • Part 1 Safety Lead-In: Incidence of dose limiting toxicities [ Time Frame: First 42 days after first elranatamab dose ]
  • Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria [ Time Frame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2021)
  • Part 1 Safety Lead-In: Incidence of dose limiting toxicities [ Time Frame: First 42 days after first elranatamab dose ]
  • Part 2 Randomized: Progression free survival by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Progression free survival by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs. daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 32 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2023)
  • Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months ]
  • Overall survival [ Time Frame: From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months ]
  • Objective response rate per International Myeloma Working Group criteria [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months ]
  • Duration of response per International Myeloma Working Group criteria [ Time Frame: From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months ]
  • Time to response per International Myeloma Working Group criteria [ Time Frame: From date of randomization to date of confirmed objective response, assessed up to 51 months ]
  • Complete response rate per International Myeloma Working Group criteria [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months ]
  • Duration of complete response per International Myeloma Working Group criteria [ Time Frame: From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months ]
  • Minimal residual disease negativity rate per International Myeloma Working Group criteria [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months ]
  • Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months ]
  • Progression free survival on next-line treatment per International Myeloma Working Group criteria [ Time Frame: From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months ]
  • Frequency of treatment-emergent adverse events [ Time Frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy. ]
  • Frequency of abnormal laboratory results [ Time Frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy. ]
  • Rate of Grade ≥2 cytokine release syndrome [ Time Frame: First 28 days after first elranatamab dose ]
  • Elranatamab pharmacokinetics by pre- and post-dose concentrations [ Time Frame: From date of first dose through up to 14 days after date of last dose of elranatamab ]
  • Elranatamab immunogenicity by anti-drug antibodies against elranatamab [ Time Frame: From date of first dose through up to 14 days after date of last dose of elranatamab ]
  • Daratumumab pharmacokinetics by pre-dose concentrations [ Time Frame: From date of first dose through up to 14 days after date of last dose of daratumumab ]
  • Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [ Time Frame: From date of informed consent through up to 35 days after date of last dose of study intervention ]
  • Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 [ Time Frame: From date of informed consent through up to 35 days after date of last dose of study intervention ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2021)
  • Part 1 Safety Lead-In: Rate of Grade ≥2 cytokine release syndrome [ Time Frame: First 28 days after first elranatamab dose ]
  • Part 1 Safety Lead-In: Frequency of treatment-emergent adverse events [ Time Frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy. ]
  • Part 1 Safety Lead-In: Frequency of abnormal laboratory results [ Time Frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy. ]
  • Part 1 Safety Lead-In: Progression free survival by investigator assessment per International Myeloma Working Group [ Time Frame: From date of first dose of study intervention to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 1 Safety Lead-In: Objective response rate per International Myeloma Working Group criteria [ Time Frame: From date of first dose of study intervention to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 1 Safety Lead-In: Duration of response per International Myeloma Working Group criteria [ Time Frame: From date of first confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 1 Safety Lead-In: Cumulative complete response rate per International Myeloma Working Group criteria [ Time Frame: From date of first dose of study intervention to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 1 Safety Lead-In: Duration of cumulative complete response per International Myeloma Working Group criteria [ Time Frame: From date of first confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 1 Safety Lead-In: Time to response per International Myeloma Working Group criteria [ Time Frame: From date of first dose of study intervention to date of confirmed objective response, assessed up to 32 months ]
  • Part 1 Safety Lead-In: Overall survival [ Time Frame: From date of first dose of study intervention to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 1 Safety Lead-In: Minimal residual disease negativity rate per International Myeloma Working Group criteria [ Time Frame: From date of first dose of study intervention to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 1 Safety Lead-In: Elranatamab pharmacokinetics by pre- and post-dose concentrations [ Time Frame: From date of first dose through up to 14 days after date of last dose of elranatamab ]
  • Part 1 Safety Lead-In: Elranatamab immunogenicity by anti-drug antibodies against elranatamab [ Time Frame: From date of first dose through up to 14 days after date of last dose of elranatamab ]
  • Part 1 Safety Lead-In: Daratumumab pharmacokinetics by pre-dose concentrations [ Time Frame: From date of first dose through up to 14 days after date of last dose of daratumumab ]
  • Part 2 Randomized: Overall survival [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Overall survival [elranatamab + daratumumab (Arm B) vs. daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of discontinuation from study, death, or censoring, assessed up to 32 months ]
  • Part 2 Randomized: Progression free survival by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Progression free survival by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Objective response rate by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Objective response rate by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Duration of response by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Duration of response by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Cumulative complete response rate by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Cumulative complete response rate by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Duration of cumulative complete response by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Duration of cumulative complete response by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of confirmed complete response to date of progressive disease, discontinuation of study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Time to response by blinded independent central review per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of confirmed objective response, assessed up to 32 months ]
  • Part 2 Randomized: Time to response by investigator assessment per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of confirmed objective response, assessed up to 32 months ]
  • Part 2 Randomized: Objective response rate by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Objective response rate by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Duration of response by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Duration of response by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Cumulative complete response rate by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Cumulative complete response rate by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Duration of cumulative complete response by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Duration of cumulative complete response by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of confirmed complete response to date of progressive disease, discontinuation of study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Time to response by blinded independent central review per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of confirmed objective response, assessed up to 32 months ]
  • Part 2 Randomized: Time to response by investigator assessment per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of confirmed objective response, assessed up to 32 months ]
  • Part 2 Randomized: Minimal residual disease negativity rate per International Myeloma Working Group criteria [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Minimal residual disease negativity rate per International Myeloma Working Group criteria [elranatamab + daratumumab (Arm B) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 32 months ]
  • Part 2 Randomized: Frequency of treatment-emergent adverse events [ Time Frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy. ]
  • Part 2 Randomized: Frequency of abnormal laboratory results [ Time Frame: From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy. ]
  • Part 2 Randomized: Elranatamab pharmacokinetics by pre- and post-dose concentrations [ Time Frame: From date of first dose through up to 14 days after date of last dose of elranatamab ]
  • Part 2 Randomized: Elranatamab immunogenicity by anti-drug antibodies against elranatamab [ Time Frame: From date of first dose through up to 14 days after date of last dose of elranatamab ]
  • Part 2 Randomized: Daratumumab pharmacokinetics by pre-dose concentrations [ Time Frame: From date of first dose through up to 14 days after date of last dose of daratumumab ]
  • Part 2 Randomized: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of informed consent through up to 35 days after date of last dose of study intervention ]
  • Part 2 Randomized: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [elranatamab + daratumumab (Arm B) vs. daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of informed consent through up to 35 days after date of last dose of study intervention ]
  • Part 2 Randomized: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 [elranatamab (Arm A) vs daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of informed consent through up to 35 days after date of last dose of study intervention ]
  • Part 2 Randomized: Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 [elranatamab + daratumumab (Arm B) vs. daratumumab + pomalidomide + dexamethasone (Arm C)] [ Time Frame: From date of informed consent through up to 35 days after date of last dose of study intervention ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Official Title  ICMJE AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
Brief Summary The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: Elranatamab
    subcutaneous
    Other Name: PF-06863135
  • Drug: Daratumumab
    Daratumumab / hyaluronidase, subcutaneous
    Other Name: Darzalex Faspro; Darzalex solution for injection
  • Drug: Pomalidomide
    oral
    Other Name: Pomalyst, Imnovid
  • Drug: Dexamethasone
    oral
Study Arms  ICMJE
  • Experimental: Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab
    Interventions:
    • Drug: Elranatamab
    • Drug: Daratumumab
  • Experimental: Part 2 Randomized Arm A: Elranatamab
    Intervention: Drug: Elranatamab
  • Experimental: Part 2 Randomized Arm B: Elranatamab + Daratumumab
    Interventions:
    • Drug: Elranatamab
    • Drug: Daratumumab
  • Active Comparator: Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
    Interventions:
    • Drug: Daratumumab
    • Drug: Pomalidomide
    • Drug: Dexamethasone
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: January 17, 2024)		 762
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2021)		 476
Estimated Study Completion Date  ICMJE September 28, 2026
Estimated Primary Completion Date December 27, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).

  • Measurable disease based on IMWG criteria as defined by at least 1 of the following:

    • Serum M-protein ≥0.5 g/dL.
    • Urinary M-protein excretion ≥200 mg/24 hours.
    • Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor.
  • 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.
  • Plasma cell leukemia.
  • Amyloidosis.
  • POEMS Syndrome.
  • Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
  • Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
  • Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • Previous treatment with a BCMA-directed therapy.
  • Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study.
  • Live attenuated vaccine within 4 weeks of the first dose of study intervention.
  • Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czechia,   Finland,   France,   Germany,   Greece,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Spain,   Sweden,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries India
 
Administrative Information
NCT Number  ICMJE NCT05020236
Other Study ID Numbers  ICMJE C1071005
2021-000044-22 ( EudraCT Number )
MAGNETISMM-5 ( 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
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2024

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