Clinical Trials Logo
  1. Home
  2. Myeloma
  3. NCT05055063

A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma

Myeloma Clinical Trial

Official title:
A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma (BELLA)

Clinical Trial Summary

This is a single-center, single arm, phase I study designed to determine the safety and find the recommended Phase 2 dose (RP2D) or maximum dose level (MTD) of Belantamab Mafodotin in patients with high-risk smoldering multiple myeloma. The study will have a dose-finding part and a dose-expansion part. The maximum number of enrolled patients will be 30 with 18 patients for the dose-finding part and 12 patients for the dose-expansion part. Once we determine the MTD or RP2D in the dose-finding part, we will enroll and treat 12 additional patients at the MTD or RP2D in the expansion part. Efficacy will be assessed through the overall response rate (ORR) at the end of the study. With the limited number of patients for the dose-expansion part, we will not have formal futility monitoring rule.

Clinical Trial Description

Primary Objective: To obtain the recommended Phase 2 dose (RP2D) or maximum tolerated dose of single agent belantamab mafodotin in high risk SMM. Secondary Objectives: Overall response rate per International Myeloma Working Group (IMWG) criteria. Progression free survival at 2 years, overall survival, duration of response, safety and clinical benefit rate. Exploratory Studies: Evaluate correlative endpoints including immune, cellular and molecular profiling, minimal residual disease, BCMA staining of bone marrow, pharmacokinetics, pharmacodynamics and mechanisms of resistance to belantamab mafodotin. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05055063
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Lisa Aoula
Phone 713-563-4898
Email lladkins@mdanderson.org
Status Recruiting
Phase Phase 1
Start date May 18, 2022
Completion date February 2, 2027
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03832127 - Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients Phase 1
Completed NCT01413178 - A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma Phase 3
Recruiting NCT03641456 - VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma Phase 2
Completed NCT03135925 - Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation N/A
Terminated NCT02907073 - Positron Emission Tomography (PET) Imaging Studies With NIS Reporter Phase 1/Phase 2
Withdrawn NCT02114502 - Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma Phase 2
Completed NCT00800839 - Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide Phase 2
Completed NCT01700608 - Prospective Observational Study on Plerixafor After Chemotherapy N/A
Completed NCT00794261 - Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma Phase 2
Completed NCT00606437 - Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants Phase 1
Recruiting NCT05528887 - Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies Phase 1
Recruiting NCT05625971 - Non-invasive MRD Assessment in Multiple Myeloma
Active, not recruiting NCT02931942 - Changing Over Time of Ascorbic Acid After Chemotherapy
Active, not recruiting NCT05889221 - Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma N/A
Recruiting NCT03836690 - Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation Phase 1
Active, not recruiting NCT02542657 - Ixazomib With Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients With Multiple Myeloma Phase 1/Phase 2
Completed NCT01191060 - Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years Phase 3
Completed NCT01279694 - Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma (CARMYSAP) Phase 1/Phase 2
Terminated NCT00983346 - Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients Phase 2
Completed NCT00476294 - Long-Term Follow Up Study for AMD3100 Patients N/A