Clinical Trials Logo
  1. Home
  2. Plasma Cell Myeloma
  3. NCT04876248

Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant

Plasma Cell Myeloma Clinical Trial

Official title:
Phase 2 Trial of Belantamab Mafodotin Consolidation Treatment in Patients With Multiple Myeloma and MRD Positivity After Autologous Stem Cell Transplantation

Clinical Trial Summary

This phase II trial investigates the effect of belantamab mafodotin and lenalidomide on minimal residual disease negative rates in patients with multiple myeloma with minimal residual disease positive after stem cell transplant. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell maturation antigen (BCMA) receptors, and delivers mafodotin to kill them. Lenalidomide may help block the formation of growths that may become cancer, and is used as a standard of care treatment for multiple myeloma. Giving belantamab mafodotin and lenalidomide may help to maintain minimal residual disease negativity in patients with multiple myeloma.

Clinical Trial Description

PRIMARY OBJECTIVE: I. Assess the minimal residual disease (MRD) negative rate after 6 cycles of post autologous stem cell transplant consolidation with belantamab mafodotin and lenalidomide. SECONDARY OBJECTIVE: I. Assess sustained MRD negative rate, progression free survival (PFS) and overall survival (OS). OUTLINE: Patients receive belantamab mafodotin intravenously (IV) over 30 minutes on day 1 and lenalidomide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 8 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 12 weeks and the periodically for up to 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04876248
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Recruiting
Phase Phase 2
Start date June 30, 2024
Completion date September 1, 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Completed NCT02513186 - Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation Phase 1
Recruiting NCT04977024 - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer Phase 2
Completed NCT02880228 - Pembrolizumab, Lenalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplant Phase 2
Recruiting NCT04782687 - Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma Phase 2
Completed NCT02514668 - A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma Phase 1
Active, not recruiting NCT03417284 - Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation Phase 1/Phase 2
Active, not recruiting NCT05142371 - Telehealth Exercise Intervention to Improve Physical Function and Frailty in Multiple Myeloma Survivors N/A
Terminated NCT03272633 - Irradiated Donor Cells Following Stem Cell Transplant in Controlling Cancer in Patients With Hematologic Malignancies Early Phase 1
Recruiting NCT05031897 - Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant Phase 2
Active, not recruiting NCT03275285 - Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients Phase 3
Completed NCT04100044 - Exercise Prescription for the Improvement of Quality of Life in Elderly Patients With Multiple Myeloma N/A
Active, not recruiting NCT00075478 - Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer Phase 3
Recruiting NCT05561387 - Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment Phase 3
Completed NCT03317899 - Stem Cell Transplant With or Without Tbo-filgrastim in Treating Patients With Multiple Myeloma or Non-Hodgkin Lymphoma Phase 2
Active, not recruiting NCT05511428 - Home Based Daratumumab Administration for Patients With Multiple Myeloma Early Phase 1
Completed NCT01919619 - Lenalidomide and Ipilimumab After Stem Cell Transplant in Treating Patients With Hematologic or Lymphoid Malignancies Phase 2
Terminated NCT02353572 - Melphalan and Bortezomib Prior to Autologous Stem Cell Transplant in Treating Patients With Multiple Myeloma Phase 1/Phase 2
Recruiting NCT04537871 - Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study
Active, not recruiting NCT00719888 - Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease Phase 2