Horizon Two: HR NDMM (MMRC-100)

Conditions

• High Risk Newly Diagnosed Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

May 2026

Primary completion

Oct 1, 2035

Completion

Oct 12, 2035

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Control Arm: Isa-KRd with Autologous Stem Cell Transplant
  Appendix A to the MMRC Horizon Two High Risk Newly Diagnosed Multiple Myeloma Master Protocol: Isa-KRd with Autologous Stem Cell Transplant in Patients with High Risk Newly Diagnosed Multiple Myeloma
• Experimental: Induction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy
  Appendix B to the MMRC Horizon Two High Risk Newly Diagnosed Multiple Myeloma Master Protocol: Induction, Consolidation, and Maintenance Therapy Combining Linvoseltamab and Triplet Therapy in Patients with High Risk Newly Diagnosed Multiple Myeloma

Primary Outcome Measure

Sustained measurable residual disease (MRD) negativity [ Time Frame: 2 years post randomization ]

Central Contacts

• Jessica Vandermark
  2036520457
  [email protected]
• Mercedes Martillo
  2036520457
  [email protected]

Locations (7)

Find similar trials in Atlanta, GA