NCT07029776

MMulti-Immune HR; Multi-Target Immunotherapy for High-Risk Multiple Myeloma

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 obtain immediate disease control, reduce tumor bulk and minimize the risk of subsequent cytokine release syndrome (CRS). Peripheral blood stem cell (PBSC) will be harvested after induction treatment. Immune therapy will consist of teclistamab+daratumumab followed sequentially by talquetamab+daratumumab each for 4 cycles. Next, an MRD-based consolidation approach will be utilized where subjects who are MRD-negative (a threshold of 10\^5) will be given 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. 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. Minimal residual disease (MRD) status with classification threshold of 10\^5 will be assessed by standardized flow cytometry.

Conditions

• Multiple Myeloma (MM)

Interventions

Type	Name	Description
DRUG	teclistamab+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.
PROCEDURE	melphalan (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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2030-04-01
• Completion: 2032-04-01
• First posted: 2025-06-19
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study