NCT07053436

Horizon Two Adaptive Platform Study in High Risk Newly Diagnosed Multiple Myeloma

MMRC Horizon Two: A Phase II Randomized Adaptive Platform Trial Integrating Novel Therapies in High-Risk-Newly Diagnosed Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Multiple Myeloma Research Consortium · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Multiple Myeloma Research Consortium (MMRC) Horizon Two trial is a master protocol, multi-center, phase II randomized adaptive platform trial designed to efficiently evaluate multiple investigational therapies in high-risk newly diagnosed multiple myeloma patients using an integrated and patient-centric clinical research platform that enables longitudinal learning and sharing of knowledge and investigates multiple novel therapeutic strategies within one trial platform.

Detailed description

The master protocol has broad scope and substantial flexibility, allowing each investigational arm within the platform to have its own design. The master protocol specifies general principles but the analysis plan for each investigational arm will be specified in its appendix. Details outlined in each investigational arm's appendix will include any co-primary endpoints (if applicable), the comparator arm, sample size and justification, inclusion of a safety run-in (if required), and any potential adaptations within the appendix. Accrual to an investigational arm will terminate in accord with its appendix. As an adaptive platform trial, MMRC Horizon Two will evaluate multiple investigational arms against common controls. It is expected that the common controls may vary over time as standard of care therapy evolves. An initial common control arm will be specified in the control arm appendix. Changes in the common controls will be made through amendments to this appendix. All patients will be randomized to an arm in the study. The default for the platform will be equal randomization to all arms that a patient is eligible. However, when there are more than two investigational arms and response adaptive randomization is deemed beneficial, it may be implemented in the trial. Participants will be on study for 5 years from the date of randomization, inclusive of treatment and follow-up periods. Specifics on treatment duration and duration of follow up will be included in the respective arm appendix.

Conditions

• High Risk Newly Diagnosed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Bispecific Monoclonal Antibody and Triplet Therapy	Induction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy
DRUG	Monoclonal Antibody with Stem Cell Transplant	Isatuximab-KRd with Autologous Stem Cell Transplant

Timeline

• Start date: 2025-10-01
• Primary completion: 2035-10-01
• Completion: 2035-10-12
• First posted: 2025-07-08
• Last updated: 2025-07-08

Regulatory

• FDA-regulated drug study