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

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-03-25

Primary completion: 2027-08-04

Study completion finish: 2029-10-31

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT05317416

Intervention or treatment

DRUG: Elranatamab

DRUG: Lenalidomide

DRUG: Elranatamab

Conditions

• Multiple Myeloma

Condition: Multiple Myeloma
DRUG: Elranatamab and other drugs
Wollongong, New South Wales, Australia and more
Sponsor: Pfizer

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Wollongong Hospital

Research sites nearby

Select from list below to view details:

Wollongong Hospital
Wollongong, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Shoalhaven District Memorial Hospital
Nowra, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Progression Free Survival	Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria	Assessed for up to approximately 5 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Overall Survival	Defined as the time from randomization until death due to any cause	Assessed for up to approximately 5 years
Minimal Residual Disease negativity rate	Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing	12 months after randomization
Sustained MRD negativity rate	Sustained Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing	24 months after randomization
Progression Free Survival	Progression Free Survival by investigator per IMWG response criteria	Assessed for up to approximately 5 years
Overall minimal residual disease negativity rate	Minimal residual disease negativity rate per IMWG criteria	Assessed for up to approximately 5 years
Duration of minimal residual disease negativity	Minimal residual disease negativity per IMWG criteria	Assessed for up to approximately 5 years
Sustained minimal residual disease negativity rate	Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months	Assessed for up to approximately 5 years
Complete response rate	Complete response rate by blinded independent central review and by investigator per IMWG criteria	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	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	Up to 90 days after last dose
Frequency of laboratory abnormalities	Not Specified	Assessed for up to approximately 5 years
Pre-dose concentrations of elranatamab	Pharmacokinetics of elranatamab (trough concentrations of elranatamab)	Assessed for up to approximately 5 years
Post-dose concentrations of elranatamab	Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"	Assessed for up to approximately 5 years
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab	Immunogenicity of elranatamab	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	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	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	Assessed for up to approximately 5 years

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant