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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 : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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 both 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Elranatamab Drug: Daratumumab Drug: Pomalidomide Drug: Dexamethasone Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 589 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 4, 2021
Estimated Primary Completion Date : October 29, 2024
Estimated Study Completion Date : December 29, 2025

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: Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab Drug: Elranatamab
subcutaneous
Other Name: PF-06863135

Drug: Daratumumab
Daratumumab / hyaluronidase, subcutaneous
Other Name: Darzalex Faspro; Darzalex solution for injection
Experimental: Part 2 Randomized Arm A: Elranatamab Drug: Elranatamab
subcutaneous
Other Name: PF-06863135
Experimental: Part 2 Randomized Arm B: Elranatamab + Daratumumab Drug: Elranatamab
subcutaneous
Other Name: PF-06863135

Drug: Daratumumab
Daratumumab / hyaluronidase, subcutaneous
Other Name: Darzalex Faspro; Darzalex solution for injection
Active Comparator: Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone Drug: Daratumumab
Daratumumab / hyaluronidase, subcutaneous
Other Name: Darzalex Faspro; Darzalex solution for injection

Drug: Pomalidomide
oral
Other Name: Pomalyst, Imnovid

Drug: Dexamethasone
oral


Outcome Measures
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Primary Outcome Measures :
  1. Part 1 Safety Lead-In: Incidence of dose limiting toxicities [ Time Frame: First 42 days after first elranatamab dose ]
  2. 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 32 months ]

Secondary Outcome Measures :
  1. 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 32 months ]
  2. Overall survival [ Time Frame: From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 32 months ]
  3. 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 32 months ]
  4. 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 32 months ]
  5. Time to response per International Myeloma Working Group criteria [ Time Frame: From date of randomization to date of confirmed objective response, assessed up to 32 months ]
  6. 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 32 months ]
  7. 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 32 months ]
  8. 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 32 months ]
  9. 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 32 months ]
  10. 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 32 months ]
  11. 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. ]
  12. 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. ]
  13. Rate of Grade ≥2 cytokine release syndrome [ Time Frame: First 28 days after first elranatamab dose ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. 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 ]
  18. 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 ]

Eligibility Criteria
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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:

  • 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.
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): NCT05020236


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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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: NCT05020236    
Other Study ID Numbers: C1071005
2021-000044-22 ( EudraCT Number )
MAGNETISMM-5 ( Other Identifier: Alias Study Number )
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 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:
Elranatamab
PF-06863135
B-Cell Maturation Antigen
BCMA
Bispecific antibody
BCMA-CD3 bispecific antibody
 Daratumumab
Pomalidomide
Multiple myeloma
Relapsed multiple myeloma
Refractory multiple myeloma
MagnetisMM-5
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
Dexamethasone
 Daratumumab
Pomalidomide
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors