The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

Geo Regions

Category

Hematological Malignancies

Elranatamab

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
Phase 3
NCT05317416

Active enrolling

Globe
Locations

United States, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom

Study design

Participant Group/Arm

EXPERIMENTAL: Arm A - Part 1

Elranatamab

Intervention/Treatment

DRUG: Elranatamab

BCMA-CD3 bispecific antibody
Participant Group/Arm

ACTIVE_COMPARATOR: Arm B - Part 1

Lenalidomide

Intervention/Treatment

DRUG: Lenalidomide

Immunomodulatory drug
Participant Group/Arm

ACTIVE_COMPARATOR: Arm B - Part 2

Lenalidomide

Intervention/Treatment

DRUG: Lenalidomide

Immunomodulatory drug
Participant Group/Arm

EXPERIMENTAL: Arm C - Part 2

Elranatamab

Intervention/Treatment

DRUG: Elranatamab

BCMA-CD3 bispecific antibody
Study design table for Clinical Trial

Key eligibility 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)

Key dates

Study start date
  • March 2022
Estimated primary completion date
  • October 2029

Key endpoints

Primary Outcome Measures
Outcome Measure

Progression Free Survival

Measure Description

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

Time Frame

Assessed for up to approximately 5 years

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Overall Survival

Measure Description

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

Time Frame

Assessed for up to approximately 5 years

Outcome Measure

Minimal Residual Disease negativity rate

Measure Description

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

Time Frame

12 months after randomization

Outcome Measure

Sustained MRD negativity rate

Measure Description

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

Time Frame

24 months after randomization

Outcome Measure

Progression Free Survival

Measure Description

Progression Free Survival by investigator per IMWG response criteria

Time Frame

Assessed for up to approximately 5 years

Outcome Measure

Overall minimal residual disease negativity rate

Measure Description

Minimal residual disease negativity rate per IMWG criteria

Time Frame

Assessed for up to approximately 5 years

Outcome Measure

Duration of minimal residual disease negativity

Measure Description

Minimal residual disease negativity per IMWG criteria

Time Frame

Assessed for up to approximately 5 years

Outcome Measure

Sustained minimal residual disease negativity rate

Measure Description

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

Time Frame

Assessed for up to approximately 5 years

Outcome Measure

Complete response rate

Measure Description

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

Time Frame

Assessed for up to approximately 5 years

Outcome Measure

Duration of complete response

Measure Description

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

Time Frame

Assessed for up to approximately 5 years

Outcome Measure

Frequency of adverse events

Measure Description

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

Outcome Measure

Frequency of laboratory abnormalities

Measure Description

Time Frame

Assessed for up to approximately 5 years

Outcome Measure

Pre-dose concentrations of elranatamab

Measure Description

Pharmacokinetics of elranatamab (trough concentrations of elranatamab)

Time Frame

Assessed for up to approximately 5 years

Outcome Measure

Post-dose concentrations of elranatamab

Measure Description

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

Time Frame

Assessed for up to approximately 5 years

Outcome Measure

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

Measure Description

Immunogenicity of elranatamab

Time Frame

Assessed for up to approximately 5 years

Outcome Measure

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

Measure Description

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

Outcome Measure

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

Measure Description

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

Outcome Measure

Progression Free Survival 2

Measure Description

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

Secondary Outcome Measures table for Clinical Trial

Number of participants

760

Collaborators and investigators

Sponsor: Pfizer

Collaborator: None

This information is current as of August 9th 2024.
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More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT05317416