Actively Recruiting
Horizon Two Adaptive Platform Study in High Risk Newly Diagnosed Multiple Myeloma
Led by Multiple Myeloma Research Consortium · Updated on 2026-05-14
300
Participants Needed
2
Research Sites
493 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Horizon Two Adaptive Platform Study in High Risk Newly Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Diagnosed with symptomatic, high-risk newly diagnosed multiple myeloma confirmed by IMWG criteria
- Eligible for transplant
- High-risk defined by at least one: Del(17p) with CCF ≥ 20%, TP53 mutation, certain translocations with +1q and/or del(1p32), monoallelic or biallelic del(1p32) with +1q, high beta-2 microglobulin (≥5.5 mg/dL) with normal creatinine, extramedullary disease not contiguous with bone, or primary plasma cell leukemia
- Received no more than 2 cycles of NCCN listed induction therapy
- Measurable disease per IMWG criteria at diagnosis
- ECOG performance status 0-2
- Adequate hematological function (ANC ≥ 1000/µL, platelets ≥ 75,000/µL, hemoglobin ≥ 8 g/dL)
- Adequate hepatic function (bilirubin ≤ 1.5 x IULN or direct bilirubin ≤ 1.5 x IULN for Gilbert syndrome, AST and ALT ≤ 2.5 x IULN)
- Adequate renal function (creatinine clearance ≥ 30 mL/min)
- Negative pregnancy test for persons of childbearing potential
- Use of highly effective contraception during study and 90 days after last dose
- Male participants with partners of childbearing potential agree to use contraception
- Cardiac function classified as NYHA Class 2 or better
- Prior or concurrent malignancies allowed if not interfering with study
- HIV positive patients on effective treatment with undetectable viral load
- Controlled hepatitis B and cured or treated hepatitis C
- Willing and able to comply with study requirements
You will not qualify if you...
- Major concurrent illnesses or organ dysfunction including POEMS syndrome or symptomatic major organ involvement AL amyloidosis
- Allergy or known hypersensitivity to any trial therapy or their components
- Complete spinal cord compression or central nervous system involvement
- Known leptomeningeal disease
- Allogeneic transplant recipients with chronic GVHD requiring >20 mg prednisone
- Active infection requiring treatment
- Conditions, therapies, or lab abnormalities that could interfere with study participation or safety
- Psychiatric or substance abuse disorders interfering with cooperation
- Legally incapacitated or limited legal capacity
- Pregnant or breastfeeding persons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Washington University Medical Center
St Louis, Missouri, United States, 63130
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
J
Jessica Vandermark
CONTACT
M
Mercedes Martillo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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