Share
Save
Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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: Lenalidomide
DRUG: Elranatamab
Conditions
- • Multiple Myeloma
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
| DRUG: Elranatamab
|
ACTIVE_COMPARATOR: Arm B - Part 1
| DRUG: Lenalidomide
|
ACTIVE_COMPARATOR: Arm B - Part 2
| DRUG: Lenalidomide
|
EXPERIMENTAL: Arm C - Part 2
| DRUG: Elranatamab
|
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
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!