RecruitingPhase 2NCT06171685

MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM

A Phase II Randomized Adaptive Platform Trial Evaluating Novel Therapies in Relapsed or Refractory Multiple Myeloma


Sponsor

Multiple Myeloma Research Consortium

Enrollment

300 participants

Start Date

Nov 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This adaptive platform trial is testing multiple new treatments for relapsed or refractory multiple myeloma (a blood cancer that has come back or stopped responding to treatment) in patients who have already tried standard drug classes. **You may be eligible if...** - You are 18 or older - You have multiple myeloma that has been exposed to, relapsed from, or become intolerant to a proteasome inhibitor, an immunomodulatory drug (IMiD), and an anti-CD38 antibody - You have had between 1 and 4 prior lines of treatment - You have measurable disease in the blood, urine, or on imaging - You are in generally good health (ECOG 0-2) - Your blood counts and organ function meet required thresholds **You may NOT be eligible if...** - You have received prior BCMA-directed therapy within the last 6 months (a washout period is required) - You do not meet blood count or organ function requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTeclistamab Monotherapy

standard of care

DRUGTeclistamab

investigational doses compared to SOC


Locations(13)

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

View Full Details on ClinicalTrials.gov

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NCT06171685


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