MMRC Horizon One: RRMM (MMRC-099)

Running, not enrolling · Phase 2

Conditions studied: Relapse Multiple Myeloma, Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06171685

Run by

Multiple Myeloma Research Consortium

People needed

300

Starts

2024-11-17

Expected to finish

2030-07-31

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For inclusion in the trial, all the following inclusion criteria must be fulfilled, as no waivers will be permitted:
• Voluntarily agree to participate by giving written informed consent
• ≥18 years of age
• Histologically confirmed multiple myeloma that is exposed, relapsed, or intolerant to one of each of the following classes of agents:
• A proteasome inhibitor
• An immunomodulatory drug
• An anti-CD38-monoclonal antibody
• Must have received between 1-4 lines of prior systemic therapy
• Prior BCMA-directed antibody-drug conjugate (ADC) or chimeric antigen receptor (CAR)-T cell therapy allowed Note: A washout period of 6 months is required from prior anti-BCMA therapy. For BCMA CAR-T cell therapy, participants must be ≥ 6 months from lymphodepleting chemotherapy.
• Measurable disease, defined as one of the following:
• M-protein ≥ 0.50g/dL (0.5 g/dL or above if IgA subtype)
• Urine M-protein (Bence-Jones protein) ≥ 200 mg/24hours
• Serum free light chain difference > 100 mg/L
• Biopsy proven plasmacytoma
• For oligosecretory multiple myeloma, disease must be measurable by imaging (i.e., PET-CT, MRI)
• 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 ≥ 50,000/µL, and hemoglobin ≥ 8 g/dL (transfusion and/or growth factor support is allowed for hematologic parameters as long as the investigator deems the participant 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 < 1.5-3.0 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)
• eGFR > 30mL/min based on MDRD 4-variable formula calculation or creatinine clearance based measured by 24h urine collection
• Corrected serum calcium <14mg/dL or free ionized calcium <6.5 mg/dL
• 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

You may not qualify if…

• For inclusion in Horizon, participants will not be eligible if any of the following criteria are met, as no waivers will be permitted:
• Major concurrent illness or organ dysfunction including but not limited to the following:
• Plasma cell leukemia (the presence of ≥ 5% circulating plasma cells in peripheral blood smears)
• Waldenström's macroglobulinemia
• POEMS syndrome
• Primary amyloid light-chain 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 cord compression or CNS involvement
• Active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
• Note: Participants with diabetes type 1, vitiligo, psoriasis, or hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
• Received a live, attenuated vaccine within 4 weeks before the first dose of study drug. Non-live or nonreplicating vaccines authorized for emergency use (eg, COVID-19) by local health authorities are allowed.
• 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 lactating

Where it is running

• City of Hope — Duarte, California, United States
• Emory Winship Cancer Center — Atlanta, Georgia, United States
• University of Chicago Cancer Center — Chicago, Illinois, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute/Harvard Medical School — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Center — Detroit, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University Medicine — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• Atrium Levine Cancer Institute — Charlotte, North Carolina, United States
• Tennessee Oncology — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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