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

Study Purpose

The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab 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.
  • - Have measurable disease at screening as defined by at least 1 of the following: a.
Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio.
  • - Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration.
  • - A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration.
  • - Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program.

Exclusion Criteria:

  • - Live, attenuated vaccine within 4 weeks 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.
- History of stroke or seizure within 6 months prior to the first dose of study treatment

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.

NCT05050097
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 & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

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

Industry
Overall Status Recruiting
Countries Australia, Belgium, France, Netherlands, 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: Talquetamab + Carfilzomib

Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion.

Experimental: Treatment Regimen B: Talquetamab + Daratumumab + Carfilzomib

Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion.

Experimental: Treatment Regimen C: Talquetamab + Lenalidomide

Participants assigned to Treatment regimen C will receive talquetamab SC in combination with lenalidomide orally.

Experimental: Treatment Regimen D: Talquetamab + Daratumumab + Lenalidomide

Participants assigned to Treatment regimen D will receive talquetamab SC in combination with daratumumab SC and lenalidomide orally.

Experimental: Treatment Regimen E: Talquetamab + Pomalidomide

Participants assigned to Treatment regimen E will receive talquetamab SC in combination with pomalidomide orally.

Interventions

Drug: - Talquetamab

Talquetamab will be administered subcutaneously.

Drug: - Carfilzomib

Carfilzomib will be administered as an IV infusion.

Drug: - Daratumumab SC

Daratumumab will be administered subcutaneously.

Drug: - Lenalidomide

Lenalidomide will be self-administered orally.

Drug: - Pomalidomide

Pomalidomide will be self-administered orally.

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 Birmingham, Birmingham, Alabama

Status

Recruiting

Address

University of Alabama 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

Indiana University, Indianapolis, Indiana

Status

Recruiting

Address

Indiana University

Indianapolis, Indiana, 46202

Hackensack University Medical Center, Hackensack, New Jersey

Status

Recruiting

Address

Hackensack University Medical Center

Hackensack, New Jersey, 07601

Mt. Sinai School of Medicine, New York, New York

Status

Recruiting

Address

Mt. Sinai School of Medicine

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

Tennessee Oncology, Nashville, Tennessee

Status

Recruiting

Address

Tennessee Oncology

Nashville, Tennessee, 37203

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

Gold Coast University Hospital, Southport, Australia

Status

Recruiting

Address

Gold Coast University Hospital

Southport, , 4215

Wollongong Hospital, Wollongong, Australia

Status

Recruiting

Address

Wollongong Hospital

Wollongong, , 2500

Cliniques Universitaires St-Luc, Brussel, Belgium

Status

Completed

Address

Cliniques Universitaires St-Luc

Brussel, , 1200

UZA, Edegem, Belgium

Status

Recruiting

Address

UZA

Edegem, , 2650

UZ Gent, Gent, Belgium

Status

Recruiting

Address

UZ Gent

Gent, , 9000

UZ Leuven, Leuven, Belgium

Status

Recruiting

Address

UZ Leuven

Leuven, , 3000

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

UMCG, Groningen, Netherlands

Status

Recruiting

Address

UMCG

Groningen, , 9713 GZ

Maastricht University Medical Centre, Maastricht, Netherlands

Status

Recruiting

Address

Maastricht University Medical Centre

Maastricht, , 6229 HX

UMCU, Utrecht, Netherlands

Status

Recruiting

Address

UMCU

Utrecht, , 3584 CX

University College Hospital London, London, United Kingdom

Status

Recruiting

Address

University College Hospital London

London, , W1T 7HA

The Christie Nhs Foundation Trust, Manchester, United Kingdom

Status

Recruiting

Address

The Christie Nhs Foundation Trust

Manchester, , M20 4BX

Churchill Hospital, Oxford, United Kingdom

Status

Recruiting

Address

Churchill Hospital

Oxford, , OX3 7LE

The Royal Marsden NHS Trust Sutton, Surrey, United Kingdom

Status

Recruiting

Address

The Royal Marsden NHS Trust Sutton

Surrey, , SM2 5PT