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Relapse Multiple MyelomaPhase 2NCT06171685

MMRC Horizon One: RRMM (MMRC-099)

A Phase 2 study testing Teclistamab Monotherapy and Teclistamab in people with Relapse Multiple Myeloma and Refractory Multiple Myeloma, run by Multiple Myeloma Research Consortium at 13 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Teclistamab Monotherapy and Teclistamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
13 sitesUnited States
Study dates
17 Nov 2024to 31 Jul 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Status is post-hysterectomy, -oophorectomy, or -tubal ligation
  • Persons of childbearing potential must be willing to use highly effective contraceptive measures during sexual contact with a person assigned as male at birth starting with the Screening visit through 90 days after last dose of trial medication.
  • Note: Abstinence is acceptable if this is the established and preferred contraception for the participant.
  • -Persons assigned as male at birth with a partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the trial starting with the Screening visit through 90 days after the last dose of trial medication is received. Persons assigned as male at birth with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
  • Note: Abstinence is acceptable if this is the established and preferred contraception method for the participant.
  • Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using New York Heart Association Functional Classification. To be eligible for this trial, participants should be Class 2 or better. Class 2 is defined as slight limitation of physical activity, in which ordinary physical activity leads to fatigue, palpitation, or dyspnea; the person is comfortable at rest.
  • Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of the investigational arms are eligible for this trial.
  • Known HIV infection who are on effective anti-retroviral therapy with undetectable viral load within 6 months of screening and enrollment are eligible for this trial.
  • Evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated.
  • History of hepatitis C virus (HCV) infection must have been treated and cured. For participants with known HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Willing and able to comply with the requirements of the protocol.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Emory Winship Cancer Center

    Atlanta, Georgia, 30322

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute/Harvard Medical School

    Boston, Massachusetts, 02215

  • Atrium Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • University of Chicago Cancer Center

    Chicago, Illinois, 60637

  • Barbara Ann Karmanos Cancer Center

    Detroit, Michigan, 48201

  • City of Hope

    Duarte, California, 91010

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10022

  • Mt. Sinai School of Medicine

    New York, New York, 10029

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Washington University Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: MMRC Horizon One: A Phase II Randomized Adaptive Platform Trial Evaluating Novel Therapies in Relapsed or Refractory Multiple Myeloma (MMRC-099)

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.

Being tested
Teclistamab Monotherapy, Teclistamab
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teclistamab MonotherapyDrug

    Also called Tecvayli

    standard of care

  • TeclistamabDrug

    Also called Tecvayli

    investigational doses compared to SOC

Study groups in NCT06171685
Study groupRoleWhat they receive
Sub-protocol AActive comparatorServes as the reference arm for the platform
Receives: Drug: Teclistamab Monotherapy
Sub-Protocol BExperimentalThis arm will be an investigational arm
Receives: Drug: Teclistamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective Response Rate

    Measured: through completion of the study, and yearly

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2023
  2. Study start17 Nov 2024
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion31 Jul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06171685
Sponsor's protocol ID
MMRC-099
Status last verified
Jun 2026
First submitted
3 Nov 2023
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Teclistamab Monotherapy and Teclistamab in people with Relapse Multiple Myeloma and Refractory Multiple Myeloma, run by Multiple Myeloma Research Consortium at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: through completion of the study, and yearly). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06171685.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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