MMRC Horizon One Adaptive Platform Trial Evaluating Therapies in RRMM

NCT06171685 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MMRC-099
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Relapse Multiple Myeloma; Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  through completion of the study, and yearly

Study Arms (2)

Sub-protocol A

ACTIVE COMPARATOR

Serves as the reference arm for the platform

Drug: Teclistamab Monotherapy

Sub-Protocol B

EXPERIMENTAL

This arm will be an investigational arm

Drug: Teclistamab

Interventions

Teclistamab Monotherapy DRUG

standard of care

Also known as: Tecvayli

Sub-protocol A

Teclistamab DRUG

investigational doses compared to SOC

Also known as: Tecvayli

Sub-Protocol B

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Multiple Myeloma Research Consortium: lead

Study Sites (13)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Emory Winship Cancer Center

Atlanta, Georgia, 30322, United States

RECRUITING

University of Chicago Cancer Center

Chicago, Illinois, 60637, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Dana Farber Cancer Institute/Harvard Medical School

Boston, Massachusetts, 02215, United States

RECRUITING

Barbara Ann Karmanos Cancer Center

Detroit, Michigan, 48201, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

Washington University Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10022, United States

RECRUITING

Mt. Sinai School of Medicine

New York, New York, 10029, United States

RECRUITING

Atrium Levine Cancer Institute

Charlotte, North Carolina, 28203, United States

RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Hearn J Cho, MD, PhD

  Multiple Myeloma Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Vandermark

CONTACT

(203) 354-7215; vandermarkj@themmrf.org

Mercedes Martillo

CONTACT

martillom@themmrf.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: December 15, 2023
• Study Start: November 17, 2024
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2030
• Last Updated: July 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)