Actively Recruiting
MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM
Led by Multiple Myeloma Research Consortium · Updated on 2025-07-15
300
Participants Needed
13
Research Sites
297 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is an adaptive platform trial. The structure of the protocol allows the trial to evolve over time. Multiple investigational arms will be included within the trial under a Master Protocol (MP). These investigational arms may be added as appendices at different times depending on whether they are trial-ready and whether accrual in the trial will support another arm. Accrual to an arm will terminate in accord with the arm's appendix to the Master Protocol. The purpose of this proposed structure is to support the recurrent research challenge of efficiently evaluating what is the best therapy for a particular patient.
CONDITIONS
Official Title
MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate by giving written informed consent
- 18 years of age or older
- Histologically confirmed multiple myeloma that is exposed, relapsed, or intolerant to a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody
- Received between 1 and 4 prior lines of systemic therapy
- Prior BCMA-directed antibody-drug conjugate or CAR-T cell therapy allowed with required washout periods
- Measurable disease by M-protein, urine M-protein, serum free light chain difference, or biopsy proven plasmacytoma
- For oligosecretory disease, measurable by imaging such as PET-CT or MRI
- ECOG performance status of 0 to 2
- Adequate hematological, hepatic, and renal function as defined by specific laboratory values
- Negative serum pregnancy test if of childbearing potential; use of effective contraception required
- Cardiac function classified as New York Heart Association Class 2 or better
- Prior or concurrent malignancies allowed if not interfering with study assessments
- Known HIV infection on effective therapy with undetectable viral load
- Chronic hepatitis B infection controlled with undetectable viral load if applicable
- History of hepatitis C treated and cured or currently on treatment with undetectable viral load
- Willing and able to comply with study requirements
You will not qualify if you...
- Major concurrent illness or organ dysfunction including plasma cell leukemia, Waldenstr�f6m's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
- History of allergy or hypersensitivity to trial therapies or their components
- Complete cord compression or central nervous system involvement
- Active or recent autoimmune disease requiring systemic treatment within 2 years, except certain controlled conditions
- Received live attenuated vaccine within 4 weeks before first study drug dose
- Allogeneic tissue or solid organ transplant recipients with chronic GVHD requiring high-dose steroids
- Active infection requiring treatment
- Any condition or therapy that may interfere with trial participation or results as judged by investigator
- Psychiatric or substance abuse disorder interfering with trial cooperation
- Legally incapacitated or limited legal capacity
- Pregnant or breastfeeding individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Emory Winship Cancer Center
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
University of Chicago Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Dana Farber Cancer Institute/Harvard Medical School
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Barbara Ann Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Actively Recruiting
7
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
8
Washington University Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
10
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10022
Actively Recruiting
11
Mt. Sinai School of Medicine
New York, New York, United States, 10029
Actively Recruiting
12
Atrium Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
13
Tennessee Oncology
Nashville, Tennessee, United States, 37203
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
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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