Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
- Registration Number
- NCT05317416
- Lead Sponsor
- Pfizer
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 760
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A - Part 1 Elranatamab Elranatamab Arm B - Part 1 Lenalidomide Lenalidomide Arm B - Part 2 Lenalidomide Lenalidomide Arm C - Part 2 Elranatamab Elranatamab
- Primary Outcome Measures
Name Time Method Minimal Residual Disease negativity rate 12 months after randomization Minimal Residual Disease negativity rate per IMWG criteria as assessed via Next Generation Sequencing
Progression Free Survival Assessed for up to approximately 5 years Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria
- Secondary Outcome Measures
Name Time Method Overall Survival Assessed for up to approximately 5 years Defined as the time from randomization until death due to any cause
Sustained MRD negative rate 24 months after randomization Sustained Minimal Residual Disease negative rate per IMWG criteria as assessed via Next Generation Sequencing
Progression Free Survival Assessed for up to approximately 5 years Progression Free Survival by investigator per IMWG response criteria
Overall minimal residual disease negative rate Assessed for up to approximately 5 years Minimal residual disease negative rate per IMWG criteria
Duration of minimal residual disease negativity Assessed for up to approximately 5 years Minimal residual disease negativity per IMWG criteria
Sustained minimal residual disease negativity rate Assessed for up to approximately 5 years Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months
Complete response rate Assessed for up to approximately 5 years Complete response rate by blinded independent central review and by investigator per IMWG criteria
Duration of complete response Assessed for up to approximately 5 years Duration of complete response by blinded independent central review and by investigator per IMWG criteria
Frequency of adverse events Up to 90 days after last dose 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
Severity of Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome Assessed for up to approximately 5 years Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome severity assessed per ASH-ASTCT criteria
Frequency of laboratory abnormalities Assessed for up to approximately 5 years Pre-dose concentrations of elranatamab Assessed for up to approximately 5 years Pharmacokinetics of elranatamab (trough concentrations of elranatamab)
Post-dose concentrations of elranatamab Assessed for up to approximately 5 years Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"
Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab Assessed for up to approximately 5 years Immunogenicity of elranatamab
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Assessed for up to approximately 5 years 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
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 Assessed for up to approximately 5 years 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
Progression Free Survival 2 Assessed for up to approximately 5 years Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria
Trial Locations
- Locations (218)
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 Hematology/Oncology - Westwood (Building 200 Suite 120)
🇺🇸Los Angeles, California, United States
UCLA Hematology/Oncology - Santa Monica
🇺🇸Los Angeles, California, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Miami Cancer Institute at Baptist Health, Inc.
🇺🇸Miami, Florida, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Scroll for more (208 remaining)Banner Gateway Medical Center🇺🇸Gilbert, Arizona, United States