Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant
NCT05317416 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 854
Last updated 2026-04-16
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
Conditions
Interventions
- DRUG
-
BCMA-CD3 bispecific antibody
- DRUG
-
Immunomodulatory drug
- DRUG
-
Immunomodulatory drug
- DRUG
-
BCMA-CD3 bispecific antibody
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-25
- Primary Completion
- 2027-08-04
- Completion
- 2029-10-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- Belgium
- Brazil
- Canada
- China
- Czechia
- Finland
- France
- Germany
- Greece
- Hungary
- India
- Israel
- Italy
- Japan
- Netherlands
- Norway
- Poland
- South Korea
- Spain
- Sweden
- Switzerland
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
More Related Trials
-
Elranatamab in R/R Multiple Myeloma
NCT06138275 ·Status: RECRUITING ·Phase: PHASE2
-
A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments
NCT05020236 ·Status: RECRUITING ·Phase: PHASE3
-
Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma
NCT06421675 ·Status: RECRUITING ·Phase: PHASE2
-
Measurable Residual Disease-Guided Post-Transplant Elranatamab Maintenance
NCT06483100 ·Status: RECRUITING ·Phase: PHASE2
-
Lenalidomide vs Placebo Maintenance Therapy Following Melphalan Prednisone Velcade® Induction Therapy in NDMM
NCT02112175 ·Status: COMPLETED ·Phase: PHASE3
-
Use of Elranatamab in Patients With High-risk Smoldering Multiple Myeloma
NCT06183489 ·Status: RECRUITING ·Phase: PHASE2
-
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients
NCT03110822 ·Status: RECRUITING ·Phase: PHASE1
-
Lenalidomide Plus Melphalan as a Preparative Regimen for Autologous Stem Cell Transplantation in Relapsed Multiple Myeloma: A Phase 1 / 2 Study
NCT01054196 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study to Compare MPR With MP in Newly Diagnosed Multiple Myeloma Subjects 65 Years Old or Older.
NCT00405756 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma
NCT01054144 ·Status: COMPLETED ·Phase: PHASE2
-
Stem Cell Transplant With Lenalidomide Maintenance in Patients With Multiple Myeloma (BMT CTN 0702)
NCT01109004 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of 25mg Versus 5 mg Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma
NCT00891384 ·Status: COMPLETED ·Phase: PHASE3
-
Continuous Lenalidomide Therapy Versus Observation Following Induction Without Lenalidomide, Pomalidomide or Thalidomide in Myeloma
NCT02155634 ·Status: WITHDRAWN ·Phase: PHASE3
-
A Study to Compare the Effects of Elranatamab (PF 06863135) Versus Standard of Care (SOC) in Patients With Multiple Myeloma (MM) in Germany and US
NCT06504524 ·Status: COMPLETED
-
2015-09: a Phase II Randomized, Open-label Study of Anti-signaling Lymphocytic Activation Molecule Monoclonal Antibody During Maintenance Therapy
NCT03000634 ·Status: WITHDRAWN ·Phase: PHASE2
-
Elotuzumab and Lenalidomide After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma
NCT02420860 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Lenalidomide Maintenance Therapy for Multiple Myeloma
NCT01675141 ·Status: TERMINATED ·Phase: PHASE2
-
Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
NCT00553644 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Learn About the Effectiveness of the Medicine Called Elranatamab in People With Relapsed Refractory Multiple Myeloma as Compared With Standard of Care Therapies
NCT06592222 ·Status: COMPLETED
-
Daratumumab in Treating Transplant-Eligible Patients With Multiple Myeloma
NCT03477539 ·Status: COMPLETED ·Phase: PHASE2
-
Elranatamab in Relapsed/Refractory Multiple Myeloma
NCT06711705 ·Status: RECRUITING ·Phase: PHASE2
-
A Safety Study of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant
NCT03106324 ·Status: ACTIVE_NOT_RECRUITING
-
Vorinostat and Lenalidomide After Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma
NCT00729118 ·Status: COMPLETED ·Phase: PHASE1
-
Determining the Feasibility of MLN9708 as Maintenance After Allogeneic Stem Cell Transplant for Multiple Myeloma
NCT02168101 ·Status: COMPLETED ·Phase: PHASE2
-
Lenalidomide and Pidilizumab in Treating Patients With Relapsed or Refractory Multiple Myeloma
NCT02077959 ·Status: TERMINATED ·Phase: PHASE1