A Phase 2 Study Exploring the Use of Bispecific Antibodies to Improve Progression Free Survival in Patients With High-Risk Newly Diagnosed Multiple Myeloma (MMulti-Immune HR)
University of Arkansas
Summary
The purpose of this research is to learn whether using teclistamab and talquetamab at different time points will improve survival in participants with high-risk Multiple Myeloma (MM). The treatment on this study will consist of Induction chemotherapy and stem cell collection, Immunotherapy 1 chemotherapy and Immunotherapy 2 chemotherapy. For participants whose testing show they are Minimal Residual Disease (MRD) positive (still have myeloma cells present in the bone marrow testing), a Melphalan-based stem cell transplant will be performed. For participants whose testing show they are MRD negative, the stem cell transplant will not be performed. All participants will go on to receive Immunotherapy 3 chemotherapy, Immunotherapy 4 chemotherapy, and Maintenance therapy.
Description
The two primary objectives are to determine (1) the Complete Response Rate (CRR) and (2) the 2-year Progression-Free Survival (PFS) percentage in participants with high-risk multiple myeloma (HRMM) treated with the sequential use of Bispecific Antibodies. Overview of Study Design: We will implement a Phase 2 clinical trial to explore the use of early and late bispecific antibodies consolidation and extended/maintenance therapy as a way of overcoming intraclonal heterogeneity and improving PFS in HRMM. Subjects will receive induction treatment with daratumumab (Dara)-KRD for 4 cycles to obtai…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have newly diagnosed active MM requiring treatment. Patients with a previous history of smoldering myeloma will be eligible if there is evidence of PD requiring initiation of treatment. * Patients must be either untreated or have not received more than two months of MM therapy. However, bisphosphonates and localized radiation are allowed. * Patients must have clinical features of high-risk disease, at time of initial diagnosis or initial assessment prior to enrollment, which may include one or more of the following: * High-risk cytogenetic abnormalities,…
Interventions
- Drugteclistamab+daratumumab followed by talquetamab+daratumumab followed by duration treatment with daratumumab and lenalidomide extended/maintenance
teclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression.
- Proceduremelphalan (MEL)-based hematopietic stem cell transplantation (HSCT) followed by drug therapy
Subjects who are MRD-positive (a threshold of 10\^5) will receive a single melphalan (MEL)-based hematopietic stem cell transplantation (HSCT) followed by teclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by a 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression.
Location
- University of Arkansas for Medical SciencesLittle Rock, Arkansas