A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant

NCT05623020
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
1,116
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Lead sponsor
Pfizer
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Start date
2022-11-10
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Number of sites
139
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Summary
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. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.
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Acronym
MagnetisMM-6
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Short title
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
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Official title
AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2033-10-03
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First posted
2022-11-21
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Registry last updated
2026-08-24
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Primary completion date
2030-10-18
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Start date
2022-11-10
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Participants
1,116
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Participant count basis
Estimated
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Planned participants
1,116
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Protocol amendments
11
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Number of sites
139
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05623020
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ClinicalTrials.gov ID
NCT05623020
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Part 1 Dose Limiting Toxicity

    Timeframe: From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide

  2. Part 2: Progression free survival per IMWG

    Timeframe: From randomization up to 97 months.

  3. Part 2: Minimal Residual Disease negative CR rate

    Timeframe: At 12 months after randomization

  1. Overall Survival

    Timeframe: From date of randomization up to 97 months

  2. Overall minimal residual disease negative CR rate

    Timeframe: From date of randomization up to 97 months

  3. Sustained MRD negative CR rate (Part 2)

    Timeframe: From date of randomization up to 97 months

  4. Duration of minimal residual disease negative CR (Part 2)

    Timeframe: From date of minimal residual disease negative CR status up to 97 months

  5. PFS by investigator

    Timeframe: From date of randomization up to 97 months

  6. PFS2 by investigator (Part 2)

    Timeframe: From the date of randomization up to 97 months

  7. Objective Response Rate

    Timeframe: From the date of randomization up to 97 months

  8. Complete Response Rate

    Timeframe: From the date of randomization up to 97 months

  9. Time to Response

    Timeframe: From the date of randomization to date of confirmed objective response up to 97 months

  10. Duration of Response

    Timeframe: From the date of confirmed objective response up to 97 months

  11. Duration of Complete Response

    Timeframe: From the date of confirmed complete response up to 97 months

  12. Frequency of treatment-emergent adverse events

    Timeframe: From the date of first dose of study intervention up to 97 months

  13. Frequency of abnormal laboratory results

    Timeframe: From the date of first dose of study intervention up to 97 months

  14. Pharmacokinetics of elranatamab when used in the elranatamab + daratumumab + lenalidomide or elranatamab + lenalidomide combinations

    Timeframe: From date of first dose of study intervention up to 97 months

    Predose and post dose concentrations of elranatamab

  15. Incidence of Anti-Drug Antibody against elranatamab

    Timeframe: From date of first dose of study intervention up to 97 months

    Immunogenicity of elranatamab

  16. Pharmacokinetics of daratumumab and lenalidomide when used in the elranatamab+daratumumab+lenalidomide or elranatamab+lenalidomide combinations (Part 1)

    Timeframe: From date of first dose of study intervention up to 97 months

    Predose concentrations of daratumumab and lenalidomide

  17. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Part 2)

    Timeframe: From date the informed consent is signed up to 97 months

    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 the symptom scales/items represent a greater presence of symptoms.

  18. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Myeloma 20 (Part 2)

    Timeframe: From date the informed consent is signed up to 97 months

    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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Diagnosis of multiple myeloma (MM) 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 (Part 1) and ≥1 g/dL (Part 2);
    • Urinary M-protein excretion ≥200 mg/24 hours;
    • Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).

  • Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant.

  • Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as:

    • Participants not considered candidates for high-dose chemotherapy and ASCT due to age or
    • Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT.

  • ECOG performance status ≤2.

  • Not pregnant and willing to use contraception

  • For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.

  • Smoldering Multiple Myeloma.
  • Monoclonal gammopathy of undetermined significance.
  • Waldenströms Macroglobulinemia
  • Plasma cell leukemia.
  • Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
  • For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.
  • For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, total of 160 mg dexamethasone or equivalent before the first dose of study intervention). A cumulative dose of systemic corticosteroids equivalent to ≥20 mg of dexamethasone during screening.
  • Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.
  • Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.
Sources for eligibility
clinicaltrials.gov

  • Jupiter Medical Center/Anderson Family Cancer InstituteJupiter, United StatesRecruiting
  • MSK Basking RidgeBasking Ridge, United StatesRecruiting
  • MSK MonmouthMiddletown, United StatesRecruiting
  • MSK BergenMontvale, United StatesRecruiting
  • MSK CommackCommack, United StatesRecruiting
  • MSK WestchesterHarrison, United StatesRecruiting
  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).New York, United StatesRecruiting
  • Memorial Sloan Kettering Cancer Center-Main CampusNew York, United StatesRecruiting
  • MSK NassauUniondale, United StatesRecruiting
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • Pindara Private HospitalBenowa, AustraliaRecruiting
  • St Vincent's Hospital MelbourneFitzroy, AustraliaRecruiting
  • Epworth FreemasonsMelbourne, AustraliaRecruiting
  • The Alfred HospitalMelbourne, AustraliaRecruiting
  • Epworth HealthcareRichmond, AustraliaRecruiting
  • Universitätsklinikum St. PöltenSankt Pölten, AustriaRecruiting
  • Krankenhaus der Barmherzigen Schwestern WienVienna, AustriaRecruiting
  • Medizinische Universität GrazGraz, AustriaRecruiting
  • Landeskrankenhaus FeldkirchRankweil, AustriaRecruiting
  • Uniklinikum SalzburgSalzburg, AustriaRecruiting
  • Medizinische Universität WienVienna, AustriaRecruiting
  • Clinique Saint PierreOttignies, BelgiumRecruiting
  • Grand Hôpital de CharleroiGilly, BelgiumRecruiting
  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site GodiYvoir, BelgiumRecruiting
  • AZ Sint-Jan Brugge-Oostende AVBruges, BelgiumNot yet recruiting

And 114 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2024-514139-50-00
  • MAGNETISMM-6
Sources for references
clinicaltrials.gov

Related records

Drugs (5)

Lead sponsors (1)

Conditions (1)

Targets (10)