Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

Phase 3Active Not RecruitingNCT05317416

Pfizer811 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

811

Conditions

Multiple Myeloma

Interventions

ElranatamabDRUG

BCMA-CD3 bispecific antibody

LenalidomideDRUG

Immunomodulatory drug

LenalidomideDRUG

Immunomodulatory drug

Elranatamab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (217)

Outcomes

Primary Outcomes

Minimal Residual Disease negativity rate

Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing

Time frame: 12 months after randomization

Progression Free Survival

Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria

Time frame: Assessed for up to approximately 5 years

Secondary Outcomes

Overall Survival

Defined as the time from randomization until death due to any cause

Time frame: Assessed for up to approximately 5 years

Sustained MRD negative rate

Sustained Minimal Residual Disease negative rate per IMWG criteria as assessed via Next Generation Sequencing

Time frame: 24 months after randomization

Progression Free Survival

Progression Free Survival by investigator per IMWG response criteria

Time frame: Assessed for up to approximately 5 years

Overall minimal residual disease negative rate

Minimal residual disease negative rate per IMWG criteria

Time frame: Assessed for up to approximately 5 years

Duration of minimal residual disease negativity

Minimal residual disease negativity per IMWG criteria

Time frame: Assessed for up to approximately 5 years

Sustained minimal residual disease negativity rate

Data from ClinicalTrials.gov

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BCMA-CD3 bispecific antibody

Banner Gateway Medical Center

Gilbert, Arizona, United States

Banner Gateway Medical Pavilion

Gilbert, Arizona, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California, United States

UCLA Hematology/Oncology

Los Angeles, California, United States

UCLA Hematology/Oncology - Santa Monica

Los Angeles, California, United States

Santa Monica UCLA Medical Center & Orthopaedic Hospital

Santa Monica, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States

...and 207 more locations

Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months

Time frame: Assessed for up to approximately 5 years

Complete response rate

Complete response rate by blinded independent central review and by investigator per IMWG criteria

Time frame: Assessed for up to approximately 5 years

Duration of complete response

Duration of complete response by blinded independent central review and by investigator per IMWG criteria

Time frame: Assessed for up to approximately 5 years

Frequency of adverse events

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

Time frame: Up to 90 days after last dose

Severity of Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome

Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome severity assessed per ASH-ASTCT criteria

Time frame: Assessed for up to approximately 5 years

Frequency of laboratory abnormalities

Time frame: Assessed for up to approximately 5 years

Pre-dose concentrations of elranatamab

Pharmacokinetics of elranatamab (trough concentrations of elranatamab)

Time frame: Assessed for up to approximately 5 years

Post-dose concentrations of elranatamab

Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"

Time frame: Assessed for up to approximately 5 years

Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab

Immunogenicity of elranatamab

Time frame: Assessed for up to approximately 5 years

Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30

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

Time frame: Assessed for up to approximately 5 years

Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20

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

Time frame: Assessed for up to approximately 5 years

Progression Free Survival 2

Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria

Time frame: Assessed for up to approximately 5 years