Actively Recruiting

Phase 2
Age: 18Years - 99Years
All Genders
NCT06171685

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

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM | DecenTrialz