Horizon Two: HR NDMM (MMRC-100)

Recruiting now · Phase 2

Conditions studied: High Risk Newly Diagnosed Multiple Myeloma

In brief

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 facts

Study ID

NCT07053436

Run by

Multiple Myeloma Research Consortium

People needed

300

Starts

2026-04-30

Expected to finish

2035-10-12

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily agree to participate by giving written informed consent
• ≥18 years of age
• Symptomatic and transplant eligible newly diagnosed multiple myeloma histologically confirmed per IMWG criteria that is high-risk as defined by at least one of the following:
• Del(17p) (CCF ≥ 20%, by analyses conducted on CD138-positive/purified cells) and/or TP53 mutation assessed by NGS
• One of these translocations-t(4;14) or t(14;16) or t(14;20)-co-occurring with +1q and/or del(1p32)
• Monoallelic del(1p32) along with +1q, or biallelic del(1p32)
• High β2M (≥5.5 mg/dL) with normal creatinine (<1.2 mg/dL)
• Presence of extra-medullary disease non-contiguous with bone at diagnosis (by PET-CT or Whole Body MRI)
• Primary plasma cell leukemia (circulating plasma cells > 5% at diagnosis)
• No more than 2 cycles of NCCN listed induction therapy for multiple myeloma
• Measurable disease, per IMWG criteria, at time of diagnosis defined as one of the following:
• Serum M-protein at diagnosis ≥ 0.5g/dL (0.3 g/dL or above if IgA subtype)
• Urine M-protein ≥ 200 mg/24hours
• Serum free light chain difference > 100 mg/L
• Plasmacytoma ≥ 2cm
• Bone marrow involvement ≥ 30%
• ECOG performance status of 0-2
• Adequate organ function, as indicated by the following laboratory values:
• Adequate hematological function, defined as ANC ≥ 1000/µL, platelet count ≥ 75,000/µL, and hemoglobin ≥ 8 g/dL (transfusion and/or growth factor support is allowed for hematologic parameters as long as the investigator deems the patient otherwise fit for screening)
• Adequate hepatic function, defined as total bilirubin level ≤ 1.5 x institutional upper limit of normal (IULN) except in participants with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5 x IULN is required), AST ≤ 2.5 x IULN, and ALT ≤ 2.5 x IULN
• Adequate renal function, defined as calculated creatinine clearance ≥ 30 mL/min per institutional standard (assessment method should be recorded, measured or C-G acceptable)
• Persons of childbearing potential must have a negative serum pregnancy test at screening (within 72 hours of first dose of trial medication). Non-childbearing potential for a person assigned as female at birth is defined as 1 of the following:
• -≥ 45 years of age and has not had menses for >1 year
• Amenorrheic for > 2 years without a hysterectomy and/or oophorectomy and follicle-stimulating hormone value in the postmenopausal range upon pretrial (screening) evaluation
• Status is post-hysterectomy, -oophorectomy, or -tubal ligation

You may not qualify if…

• Major concurrent illness or organ dysfunction including but not limited to the following:
• POEMS syndrome
• Symptomatic major organ involvement AL amyloidosis
• History of allergy or known hypersensitivity to any of the trial therapies or any of their excipients, or contraindication to any of the trial therapies as outlined in the local prescribing information (e.g., United States Prescribing Information [USPI])
• Complete spinal cord compression or CNS involvement
• Known leptomeningeal disease
• Allogeneic tissue/solid organ transplant recipients with chronic GVHD requiring steroid equivalent dose of > 20 mg prednisone
• Active infection requiring treatment
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
• Psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
• Legally incapacitated or has limited legal capacity
• Persons who are pregnant or breastfeeding

Where it is running

• Emory University — Atlanta, Georgia, United States (enrolling)
• UChicago Medicine — Chicago, Illinois, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Washington University Medical Center — St Louis, Missouri, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• UNC — Chapel Hill, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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