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Multiple MyelomaPhase 1MajesTEC-2NCT04722146

A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

A Phase 1 study testing Teclistamab, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 27 sites in 5 countries.

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

The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Teclistamab, Daratumumab and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
27 sitesin 5 countries
Study dates
12 Mar 2021to 13 Oct 2027
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
  • Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab [tec]-daratumumab [dara]-pomalidomide [pom]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide [len]-bortezomib [bor]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat [niro]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma
  • Have measurable disease at screening as defined by at least one of the following: serum M-protein level >= 1.0 gram/deciliter (g/dL); or urine M-protein level >= 200 milligrams (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
  • A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration and must agree to further serum or urine pregnancy tests during the study
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study treatment

Who cannot join

  • Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This exclusion does not apply to Treatment Regimen C
  • Live, attenuated vaccine within 30 days before the first dose of study treatment
  • Received a cumulative dose of corticosteroids equivalent to >= 140 mg of prednisone within the 14-day period before the start of study treatment administration
  • Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
  • Known to be seropositive for human immunodeficiency virus

Trial locations and contacts

27 sites in 5 countries.

27 sites in 5 countries

United States14 sites

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • Weill Cornell Medical College

    New York, New York, 10065

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • University of California San Francisco

    San Francisco, California, 94143

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Washington University School Of Medicine

    St Louis, Missouri, 63110-1032

Other trials in United States

France5 sites

  • Centre Leon Berard

    Lyon, 69373

  • CHU Nantes

    Nantes, 44093

  • CHU de Bordeaux - Hospital Haut-Leveque

    Pessac, 33604

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000

  • Institut Universitaire du cancer de Toulouse-Oncopole

    Toulouse, 31059

Other trials in France

Australia3 sites

  • St Vincents Hospital Melbourne

    Fitzroy, 3065

  • Alfred Health

    Melbourne, 3004

  • Calvary Mater Newcastle Hospital

    Waratah, 2298

Other trials in Australia

United Kingdom3 sites

  • University College Hospital

    London, NW1 2BU

  • The Christie Nhs Foundation Trust

    Manchester, M20 4BX

  • The Royal Marsden NHS Trust Sutton

    Surrey, SM2 5PT

Other trials in United Kingdom

Belgium2 sites

  • UZA

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

Other trials in Belgium

About this study

Official title: A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.

Being tested
Teclistamab, Daratumumab, Pomalidomide, Lenalidomide, Bortezomib
Medical subject headings
Multiple Myeloma

What participants receive

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

  • TeclistamabDrug

    Also called JNJ-64007957

    Participants will receive teclistamab.

  • DaratumumabDrug

    Participants will receive daratumumab.

  • PomalidomideDrug

    Participants will receive pomalidomide.

  • LenalidomideDrug

    Participants will receive lenalidomide.

  • BortezomibDrug

    Participants will receive bortezomib.

  • NirogacestatDrug

    Participants will receive nirogacestat.

Study groups in NCT04722146
Study groupRoleWhat they receive
Treatment Regimen A: Teclistamab + Daratumumab + PomalidomideExperimentalParticipants will receive teclistamab plus daratumumab plus pomalidomide.
Receives: Drug: Teclistamab; Drug: Daratumumab; Drug: Pomalidomide
Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)ExperimentalParticipants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.
Receives: Drug: Teclistamab; Drug: Daratumumab; Drug: Lenalidomide; Drug: Bortezomib
Treatment Regimen C: Teclistamab + NirogacestatExperimentalParticipants will receive teclistamab plus nirogacestat.
Receives: Drug: Teclistamab; Drug: Nirogacestat
Treatment Regimen D: Teclistamab + LenalidomideExperimentalParticipants will receive teclistamab plus lenalidomide.
Receives: Drug: Teclistamab; Drug: Lenalidomide
Treatment Regimen E: Teclistamab + Daratumumab + LenalidomideExperimentalParticipants will receive teclistamab plus daratumumab plus lenalidomide.
Receives: Drug: Teclistamab; Drug: Daratumumab; Drug: Lenalidomide
Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)ExperimentalParticipants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.
Receives: Drug: Teclistamab; Drug: Daratumumab; Drug: Lenalidomide; Drug: Bortezomib

What is being measured

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

  1. Number of Participants with Incidence of Adverse Events (AEs)

    An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.

    Measured: Up to 2 year and 5 months

  2. Number of Participants with AEs by Severity

    Number of participants with AEs by severity will be reported.

    Measured: Up to 2 year and 5 months

  3. Number of Participants with Abnormalities in Laboratory Values

    Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.

    Measured: Up to 2 year and 5 months

  4. Number of Participants with Dose-Limiting Toxicity (DLT)

    The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.

    Measured: Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)

Secondary outcomes (12)

  1. Overall Response Rate (ORR)

    ORR is defined as the proportion of participants who achieve partial response (PR) or better according to the international myeloma working group (IMWG) 2016 criteria.

    Measured: Up to 2 year and 5 months

  2. Very Good Partial Response (VGPR) or Better Response Rate

    VGPR or better response rate is defined as the proportion of participants who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria.

    Measured: Up to 2 year and 5 months

  3. Complete Response (CR) or Better Response Rate

    CR or better response rate is defined as the proportion of participants who achieve a CR or better response (sCR+CR) according to the IMWG 2016 criteria.

    Measured: Up to 2 year and 5 months

  4. Stringent Complete Response (sCR) Rate

    sCR rate is defined as the proportion of participants who achieve an sCR according to the IMWG 2016 criteria.

    Measured: Up to 2 year and 5 months

  5. Duration of Response

    Duration of response is defined as time from date of initial documentation of a response (PR or better) to date of first documented evidence of progressive disease (PD), per IMWG criteria.

    Measured: Up to 2 year and 5 months

  6. Time to Response

    Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better.

    Measured: Up to 2 year and 5 months

  7. Serum Concentrations of Teclistamab

    Serum concentrations of teclistamab will be reported.

    Measured: Up to 2 year and 5 months

  8. Serum Concentrations of Daratumumab

    Serum concentrations of daratumumab will be reported.

    Measured: Up to 2 year and 5 months

  9. Serum Concentrations of Nirogacestat

    Serum concentration of nirogacestat will be reported.

    Measured: Up to 2 year and 5 months

  10. Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab

    Number of participants with anti-drug antibodies to teclistamab will be reported for all treatment regimens.

    Measured: Up to 2 year and 5 months

  11. Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab

    Number of participants with anti-drug antibodies to daratumumab will be reported for Treatment Regimen A, B, E and F.

    Measured: Up to 2 year and 5 months

  12. Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)

    Number of participants with anti-drug antibodies to rHuPH20 will be reported for Treatment Regimen A, B, E and F.

    Measured: Up to 2 year and 5 months

Timeline

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

  1. First posted25 Jan 2021
  2. Study start12 Mar 2021
  3. Primary completion3 Oct 2025
  4. Study completion13 Oct 2027 (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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04722146
Sponsor's protocol ID
CR108927
Other IDs
64007957MMY1004, 2020-004404-33, 2023-503440-14-00, 2023
Acronym
MajesTEC-2
Status last verified
Nov 2026
First submitted
20 Jan 2021
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Teclistamab, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Janssen Research & Development, LLC at 27 sites in 5 countries.

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 5 inclusion and 5 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, France, Australia, United Kingdom, Belgium. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Number of Participants with Incidence of Adverse Events (AEs) (time frame: Up to 2 year and 5 months). The study lists 4 primary outcomes in all. 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 NCT04722146.

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 3 Nov 2026.

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