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Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant (MagnetisMM-7)

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ClinicalTrials.gov Identifier: NCT05317416
Recruitment Status : Recruiting
First Posted : April 7, 2022
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Elranatamab Drug: Lenalidomide Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION
Actual Study Start Date : March 25, 2022
Estimated Primary Completion Date : August 4, 2027
Estimated Study Completion Date : October 31, 2029

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: Arm A - Part 1
Elranatamab
 Drug: Elranatamab
BCMA-CD3 bispecific antibody
Active Comparator: Arm B - Part 1
Lenalidomide
 Drug: Lenalidomide
Immunomodulatory drug
Active Comparator: Arm B - Part 2
Lenalidomide
 Drug: Lenalidomide
Immunomodulatory drug
Experimental: Arm C - Part 2
Elranatamab
 Drug: Elranatamab
BCMA-CD3 bispecific antibody


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: Assessed for up to approximately 5 years ]
    Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Assessed for up to approximately 5 years ]
    Defined as the time from randomization until death due to any cause

  2. Minimal Residual Disease negativity rate [ Time Frame: 12 months after randomization ]
    Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing

  3. Sustained MRD negativity rate [ Time Frame: 24 months after randomization ]
    Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing

  4. Progression Free Survival [ Time Frame: Assessed for up to approximately 5 years ]
    Progression Free Survival by investigator per IMWG response criteria

  5. Overall minimal residual disease negativity rate [ Time Frame: Assessed for up to approximately 5 years ]
    Minimal residual disease negativity rate per IMWG criteria

  6. Duration of minimal residual disease negativity [ Time Frame: Assessed for up to approximately 5 years ]
    Minimal residual disease negativity per IMWG criteria

  7. Sustained minimal residual disease negativity rate [ Time Frame: Assessed for up to approximately 5 years ]
    Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months

  8. Complete response rate [ Time Frame: Assessed for up to approximately 5 years ]
    Complete response rate by blinded independent central review and by investigator per IMWG criteria

  9. Duration of complete response [ Time Frame: Assessed for up to approximately 5 years ]
    Duration of complete response by blinded independent central review and by investigator per IMWG criteria

  10. Frequency of adverse events [ Time Frame: Up to 90 days after last dose ]
    Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention

  11. Frequency of laboratory abnormalities [ Time Frame: Assessed for up to approximately 5 years ]
  12. Pre-dose concentrations of elranatamab [ Time Frame: Assessed for up to approximately 5 years ]
    Pharmacokinetics of elranatamab (trough concentrations of elranatamab)

  13. Post-dose concentrations of elranatamab [ Time Frame: Assessed for up to approximately 5 years ]
    Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"

  14. Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab [ Time Frame: Assessed for up to approximately 5 years ]
    Immunogenicity of elranatamab

  15. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 [ Time Frame: Assessed for up to approximately 5 years ]
    Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms

  16. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 [ Time Frame: Assessed for up to approximately 5 years ]
    Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms

  17. Progression Free Survival 2 [ Time Frame: Assessed for up to approximately 5 years ]
    Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria


Eligibility Criteria
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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 MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
  • Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
  • History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
  • Partial Response or better according to IMWG criteria at the time of randomization
  • Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
  • ECOG performance status ≤1
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
  • Not pregnant and willing to use contraception

Exclusion Criteria:

  • Plasma cell leukemia
  • Amyloidosis, Waldenström's macroglobulinemia
  • POEMS syndrome
  • Known active CNS involvement or clinical signs of myelomatous meningeal involvement
  • Previous MM maintenance treatment
  • Prior treatment with BCMA targeted therapy
  • 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
  • Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
  • Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) 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): NCT05317416


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: NCT05317416    
Other Study ID Numbers: C1071007
2021-006052-14 ( EudraCT Number )
MagnetisMM-7 ( Other Identifier: Alias Study Number )
First Posted: April 7, 2022    Key Record Dates
Last Update Posted: April 30, 2024
Last Verified: April 2024
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:
BCMA
Multiple Myeloma
Newly diagnosed
Elranatamab
Targeted T-cell
MagnetisMM
MM7
Phase 3
 B-cell Maturation Antigen
monoclonal antibody
Stem cell transplant
Autologous stem cell transplant (ASCT)
Hematologic disease
Minimum residual disease
Lenalidomide
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
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents