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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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 100 days after the last dose of study treatment.

Exclusion Criteria:

  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04722146
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research and Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research and Development LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belgium, France, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Arms & Interventions

Arms

Experimental: Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide

Participants will receive teclistamab plus daratumumab plus pomalidomide.

Experimental: Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles)

Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles.

Experimental: Treatment Regimen C: Teclistamab + Nirogacestat

Participants will receive teclistamab plus nirogacestat.

Experimental: Treatment Regimen D: Teclistamab + Lenalidomide

Participants will receive teclistamab plus lenalidomide.

Experimental: Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide

Participants will receive teclistamab plus daratumumab plus lenalidomide.

Experimental: Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles)

Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles.

Interventions

Drug: - Teclistamab

Participants will receive teclistamab.

Drug: - Daratumumab

Participants will receive daratumumab.

Drug: - Pomalidomide

Participants will receive pomalidomide.

Drug: - Lenalidomide

Participants will receive lenalidomide.

Drug: - Bortezomib

Participants will receive bortezomib.

Drug: - Nirogacestat

Participants will receive nirogacestat.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143

Colorado Blood Cancer Institute, Denver, Colorado

Status

Recruiting

Address

Colorado Blood Cancer Institute

Denver, Colorado, 80218

Emory University, Atlanta, Georgia

Status

Recruiting

Address

Emory University

Atlanta, Georgia, 30322

Indianapolis, Indiana

Status

Recruiting

Address

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

University of Kansas, Westwood, Kansas

Status

Withdrawn

Address

University of Kansas

Westwood, Kansas, 66205

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110-1032

Hackensack University Medical Center, Hackensack, New Jersey

Status

Recruiting

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021

Mount Sinai Medical Center, New York, New York

Status

Withdrawn

Address

Mount Sinai Medical Center

New York, New York, 10029

Weill Cornell Medical College, New York, New York

Status

Recruiting

Address

Weill Cornell Medical College

New York, New York, 10065

Levine Cancer Institute, Charlotte, North Carolina

Status

Recruiting

Address

Levine Cancer Institute

Charlotte, North Carolina, 28204

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232

Sarah Cannon Research Institute, Nashville, Tennessee

Status

Recruiting

Address

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Seattle Cancer Care Alliance, Seattle, Washington

Status

Recruiting

Address

Seattle Cancer Care Alliance

Seattle, Washington, 98109

Medical College Of Wisconsin, Milwaukee, Wisconsin

Status

Recruiting

Address

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226

International Sites

St. Vincent's Hospital Melbourne, Fitzroy, Australia

Status

Recruiting

Address

St. Vincent's Hospital Melbourne

Fitzroy, , 3065

Alfred Health, Melbourne, Australia

Status

Recruiting

Address

Alfred Health

Melbourne, , 3004

Calvary Mater Newcastle Hospital, Waratah, Australia

Status

Recruiting

Address

Calvary Mater Newcastle Hospital

Waratah, , 2298

UZA, Edegem, Belgium

Status

Active, not recruiting

Address

UZA

Edegem, , 2650

UZ Gent, Gent, Belgium

Status

Active, not recruiting

Address

UZ Gent

Gent, , 9000

Centre Leon Bérard, Lyon Cedex 8, France

Status

Recruiting

Address

Centre Leon Bérard

Lyon Cedex 8, , 69373

CHU Nantes, Nantes Cedex 1, France

Status

Recruiting

Address

CHU Nantes

Nantes Cedex 1, , 44093

CHU de Bordeaux - Hospital Haut-Leveque, Pessac cedex, France

Status

Recruiting

Address

CHU de Bordeaux - Hospital Haut-Leveque

Pessac cedex, , 33604

Chu Rennes - Hopital Pontchaillou, Rennes, France

Status

Recruiting

Address

Chu Rennes - Hopital Pontchaillou

Rennes, , 35000

TOULOUSE Cedex 9, France

Status

Recruiting

Address

Institut Universitaire du cancer de Toulouse-Oncopole

TOULOUSE Cedex 9, , 31059

University College Hospital, London, United Kingdom

Status

Recruiting

Address

University College Hospital

London, , NW1 2BU

The Christie Nhs Foundation Trust, Manchester, United Kingdom

Status

Recruiting

Address

The Christie Nhs Foundation Trust

Manchester, , M20 4BX

The Royal Marsden NHS Trust Sutton, Surrey, United Kingdom

Status

Recruiting

Address

The Royal Marsden NHS Trust Sutton

Surrey, , SM2 5PT