A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

Study Purpose

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

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 a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria.
  • - Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment.
  • - Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.
  • - A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.
  • - A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment.

Exclusion Criteria:

  • - Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams [mg] dexamethasone or equivalent).
In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=) 20 mg of dexamethasone within 14 days before randomization.
  • - Had plasmapheresis within 28 days of randomization.
  • - Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization.
  • - Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients.
  • - Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
- Myeloma Frailty Index of >=2 with the exception of participants who have a score of 2 based on age alone

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.

NCT05552222
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 3
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, Brazil, Canada, China, Czechia, France, Germany, Greece, Israel, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom
Conditions

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

Multiple Myeloma
Arms & Interventions

Arms

Experimental: Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR)

Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide.

Experimental: Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR)

Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide.

Active Comparator: Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)

Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone.

Interventions

Drug: - Teclistamab

Teclistamab will be administered as SC injection.

Drug: - Daratumumab

Daratumumab will be administered as SC injection.

Drug: - Lenalidomide

Lenalidomide will be administered orally.

Drug: - Dexamethasone

Dexamethasone will be administered either orally or intravenously (IV).

Drug: - Talquetamab

Talquetamab will be administered as SC injection.

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.

International Sites

Royal Prince Alfred Hospital, Camperdown, Australia

Status

Recruiting

Address

Royal Prince Alfred Hospital

Camperdown, , 2050

Geelong, Australia

Status

Recruiting

Address

Barwon Health - University Hospital Geelong

Geelong, , 3220

Calvary Mater Newcastle Hospital, New South Wales, Australia

Status

Recruiting

Address

Calvary Mater Newcastle Hospital

New South Wales, , 2298

Wollongong Hospital, Wollongong, Australia

Status

Recruiting

Address

Wollongong Hospital

Wollongong, , 2500

Princess Alexandra Hospital, Woolloongabba, Australia

Status

Recruiting

Address

Princess Alexandra Hospital

Woolloongabba, , 4102

Institut Jules Bordet, Anderlecht, Belgium

Status

Recruiting

Address

Institut Jules Bordet

Anderlecht, , 1070

Ghent University Hospital, Gent, Belgium

Status

Recruiting

Address

Ghent University Hospital

Gent, , 9000

Jolimont, Haine Saint Paul La Louviere, Belgium

Status

Completed

Address

Jolimont

Haine Saint Paul La Louviere, , 7100

Az Groeninge, Kortrijk, Belgium

Status

Recruiting

Address

Az Groeninge

Kortrijk, , 8500

Universitair Ziekenhuis Leuven, Leuven, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis Leuven

Leuven, , 3000

GZA Ziekenhuizen- Campus St Augustinus, Wilrijk, Belgium

Status

Recruiting

Address

GZA Ziekenhuizen- Campus St Augustinus

Wilrijk, , 2610

Liga Norte Riograndense Contra O Cancer, Natal, Brazil

Status

Recruiting

Address

Liga Norte Riograndense Contra O Cancer

Natal, , 59062-000

Hospital Sao Rafael, Salvador, Brazil

Status

Recruiting

Address

Hospital Sao Rafael

Salvador, , 41235-190

Clinica Medica Sao Germano S/S LTDA, Sao Paulo, Brazil

Status

Recruiting

Address

Clinica Medica Sao Germano S/S LTDA

Sao Paulo, , 04537-081

Sao Paulo, Brazil

Status

Recruiting

Address

Hospital Das Clinicas Da Faculdade De Medicina Da USP

Sao Paulo, , 05403-000

Calgary, Alberta, Canada

Status

Recruiting

Address

Tom Baker Cancer Center University of Calgary

Calgary, Alberta, T2N 4N2

Fu Zhou, China

Status

Recruiting

Address

Fujian Meidical University Union Hospital

Fu Zhou, , 350001

Sun Yat -Sen University Cancer Center, Guangzhou, China

Status

Recruiting

Address

Sun Yat -Sen University Cancer Center

Guangzhou, , 511363

Shanghai, China

Status

Recruiting

Address

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , 200127

Shanghai Fourth People s Hospital, Shanghai, China

Status

Recruiting

Address

Shanghai Fourth People s Hospital

Shanghai, , 200434

Tian Jin, China

Status

Recruiting

Address

Institute of Hematology and Blood Diseases Hospital

Tian Jin, , 300020

WuHan, China

Status

Recruiting

Address

Wuhan Tongji Hospital Tongji Medical College

WuHan, , 430032

Fakultni nemocnice Brno, Brno - Bohunice, Czechia

Status

Recruiting

Address

Fakultni nemocnice Brno

Brno - Bohunice, , 625 00

Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czechia

Status

Recruiting

Address

Fakultni nemocnice Hradec Kralove

Hradec Kralove, , 500 05

Fakultni nemocnice Olomouc, Olomouc, Czechia

Status

Recruiting

Address

Fakultni nemocnice Olomouc

Olomouc, , 779 00

Fakultni nemocnice Ostrava, Ostrava, Czechia

Status

Recruiting

Address

Fakultni nemocnice Ostrava

Ostrava, , 708 52

Fakultni nemocnice Plzen, Plzen, Czechia

Status

Recruiting

Address

Fakultni nemocnice Plzen

Plzen, , 304 60

VFN v Praze, Praha, Czechia

Status

Recruiting

Address

VFN v Praze

Praha, , 128 08

APHP - Hopital Henri Mondor, Creteil, France

Status

Recruiting

Address

APHP - Hopital Henri Mondor

Creteil, , 94010

Hopital Claude Huriez, Lille, France

Status

Recruiting

Address

Hopital Claude Huriez

Lille, , 59000

CHU Nantes, Nantes, France

Status

Recruiting

Address

CHU Nantes

Nantes, , 44093

CHU Hopital Saint Antoine, PARIS cedex 12, France

Status

Recruiting

Address

CHU Hopital Saint Antoine

PARIS cedex 12, , 75012

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

Status

Recruiting

Address

CHU de Bordeaux - Hospital Haut-Leveque

Pessac cedex, , 33604

CHU Lyon Sud, Pierre-Benite, France

Status

Recruiting

Address

CHU Lyon Sud

Pierre-Benite, , 69310

CHU Poitiers - Hopital la Miletrie, Poitiers, France

Status

Recruiting

Address

CHU Poitiers - Hopital la Miletrie

Poitiers, , 86021

CHU de Rennes - Hopital Pontchaillou, Rennes, France

Status

Recruiting

Address

CHU de Rennes - Hopital Pontchaillou

Rennes, , 35033

Toulouse, France

Status

Recruiting

Address

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, , 31000

Helios Kliniken Berlin Buch Gmbh, Berlin, Germany

Status

Recruiting

Address

Helios Kliniken Berlin Buch Gmbh

Berlin, , 13125

Klinikum Nuernberg Nord, Nuernberg, Germany

Status

Recruiting

Address

Klinikum Nuernberg Nord

Nuernberg, , 90419

Tübingen, Germany

Status

Recruiting

Address

Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

Tübingen, , 72076

Universitaetsklinikum Wuerzburg, Würzburg, Germany

Status

Recruiting

Address

Universitaetsklinikum Wuerzburg

Würzburg, , 97080

Alexandra General Hospital of Athens, Athens Attica, Greece

Status

Recruiting

Address

Alexandra General Hospital of Athens

Athens Attica, , 115 28

G Papanikolaou Hospital of Thessaloniki, Thessalonikis, Greece

Status

Recruiting

Address

G Papanikolaou Hospital of Thessaloniki

Thessalonikis, , 570 10

Thessaloniki, Greece

Status

Recruiting

Address

Anticancer Hospital of Thessaloniki Theageneio

Thessaloniki, , 546 39

Rambam Medical Center, Haifa, Israel

Status

Recruiting

Address

Rambam Medical Center

Haifa, , 3109601

Rabin, Petah Tikva, Israel

Status

Recruiting

Address

Rabin

Petah Tikva, , 49100

Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center

Ramat Gan, , 52621

Tel Aviv Sourasky Medical Center, Tel Aviv Yafo, Israel

Status

Recruiting

Address

Tel Aviv Sourasky Medical Center

Tel Aviv Yafo, , 6423906

A O U Sant Orsola Malpighi, Bologna, Italy

Status

Recruiting

Address

A O U Sant Orsola Malpighi

Bologna, , 40138

Ospedale San Raffaele, Milan, Italy

Status

Recruiting

Address

Ospedale San Raffaele

Milan, , 20132

Pavia, Italy

Status

Recruiting

Address

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, , 27100

Roma, Italy

Status

Recruiting

Address

Universita Degli Studi di Roma Tor Vergata

Roma, , 00133

Istituto Clinico Humanitas, Rozzano, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas

Rozzano, , 20089

Torino, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, , 10126

Kansai Medical University Hospital, Hirakata, Japan

Status

Recruiting

Address

Kansai Medical University Hospital

Hirakata, , 573-1191

Kanazawa University Hospital, Kanazawa, Japan

Status

Recruiting

Address

Kanazawa University Hospital

Kanazawa, , 920-8641

Yamagata University Hospital, Yamagata, Japan

Status

Recruiting

Address

Yamagata University Hospital

Yamagata, , 990-2331

Yamanashi Prefectural Central Hospital, Yamanashi, Japan

Status

Recruiting

Address

Yamanashi Prefectural Central Hospital

Yamanashi, , 400-8506

Dong-A University Hospital, Busan, Korea, Republic of

Status

Recruiting

Address

Dong-A University Hospital

Busan, , 49201

Pusan National University Hospital, Busan, Korea, Republic of

Status

Recruiting

Address

Pusan National University Hospital

Busan, , 49241

National Cancer Center, Goyang si, Korea, Republic of

Status

Recruiting

Address

National Cancer Center

Goyang si, , 10408

Hwasun, Korea, Republic of

Status

Recruiting

Address

Chonnam National University Hwasun Hospital

Hwasun, , 58128

Gachon University Gil Medical Center, Incheon, Korea, Republic of

Status

Recruiting

Address

Gachon University Gil Medical Center

Incheon, , 21565

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Seoul, Korea, Republic of

Status

Recruiting

Address

Severance Hospital Yonsei University Health System

Seoul, , 03722

Asan Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center

Seoul, , 05505

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 06351

Seoul, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, , 06591

VUMC Amsterdam, Amsterdam, Netherlands

Status

Recruiting

Address

VUMC Amsterdam

Amsterdam, , 1081 HV

Gelre Ziekenhuis, Apeldoorn, Netherlands

Status

Recruiting

Address

Gelre Ziekenhuis

Apeldoorn, , 7334 DZ

St. Antonius Ziekenhuis Nieuwegein, Nieuwegein, Netherlands

Status

Recruiting

Address

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, , 3435 CM

Zuyderland Medical Center, Sittard-Geleen, Netherlands

Status

Recruiting

Address

Zuyderland Medical Center

Sittard-Geleen, , 6162 BG

Oslo, Norway

Status

Recruiting

Address

Oslo University Hospital HF Ulleval sykehus

Oslo, , 0450

St. Olavs Hospital, Trondheim, Norway

Status

Recruiting

Address

St. Olavs Hospital

Trondheim, , 7030

Pratia Onkologia Katowice, Katowice, Poland

Status

Recruiting

Address

Pratia Onkologia Katowice

Katowice, , 40-519

Kielce, Poland

Status

Recruiting

Address

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, , 25-734

Ccab - Hosp. de Braga, Braga, Portugal

Status

Recruiting

Address

Ccab - Hosp. de Braga

Braga, , 4710-243

Lisbon, Portugal

Status

Recruiting

Address

Champalimaud Foundation Champalimaud Centre

Lisbon, , 1400-038

Uls Hosp. Sao Joao, Porto, Portugal

Status

Recruiting

Address

Uls Hosp. Sao Joao

Porto, , 4200-319

Hosp. Univ. Germans Trias I Pujol, Badalona, Spain

Status

Recruiting

Address

Hosp. Univ. Germans Trias I Pujol

Badalona, , 08916

Hosp. de La Santa Creu I Sant Pau, Barcelona, Spain

Status

Recruiting

Address

Hosp. de La Santa Creu I Sant Pau

Barcelona, , 08025

Hosp. Univ. Virgen de Las Nieves, Granada, Spain

Status

Recruiting

Address

Hosp. Univ. Virgen de Las Nieves

Granada, , 18014

Hosp. de Jerez de La Frontera, Jerez de la Frontera, Spain

Status

Recruiting

Address

Hosp. de Jerez de La Frontera

Jerez de la Frontera, , 11407

Hosp. Univ. 12 de Octubre, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. 12 de Octubre

Madrid, , 28041

Hosp. Univ. La Paz, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. La Paz

Madrid, , 28046

Hosp. Univ. Hm Sanchinarro, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. Hm Sanchinarro

Madrid, , 28050

Hosp. Univ. Son Espases, Palma de Mallorca, Spain

Status

Recruiting

Address

Hosp. Univ. Son Espases

Palma de Mallorca, , 07120

Hosp Clinico Univ de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hosp Clinico Univ de Salamanca

Salamanca, , 37007

Hosp. Mutua Terrassa, Terrassa, Spain

Status

Recruiting

Address

Hosp. Mutua Terrassa

Terrassa, , 08221

Hosp. Clinico Univ. de Valencia, Valencia, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Valencia

Valencia, , 46010

Falu Lasarett, Falun, Sweden

Status

Recruiting

Address

Falu Lasarett

Falun, , 791 82

Skanes universitetssjukhus, Lund, Sweden

Status

Recruiting

Address

Skanes universitetssjukhus

Lund, , 221 85

Karolinska University Hospital, Huddinge, Stockholm, Sweden

Status

Recruiting

Address

Karolinska University Hospital, Huddinge

Stockholm, , 141 86

Universitetssjukhuset Orebro, Örebro, Sweden

Status

Recruiting

Address

Universitetssjukhuset Orebro

Örebro, , 701 85

INSELSPITAL Universitatsspital Bern, Bern, Switzerland

Status

Recruiting

Address

INSELSPITAL Universitatsspital Bern

Bern, , 3010

Kantonsspital St Gallen, St. Gallen, Switzerland

Status

Recruiting

Address

Kantonsspital St Gallen

St. Gallen, , 9007

Ankara University Medical Faculty, Ankara, Turkey

Status

Recruiting

Address

Ankara University Medical Faculty

Ankara, , 06590

Liv Hospital Ankara, Ankara, Turkey

Status

Recruiting

Address

Liv Hospital Ankara

Ankara, , 06680

Dokuz Eylul University Medical Faculty, Izmir, Turkey

Status

Completed

Address

Dokuz Eylul University Medical Faculty

Izmir, , 35340

Ondokuz Mayis University, Samsun, Turkey

Status

Recruiting

Address

Ondokuz Mayis University

Samsun, , 55280

Blackpool Victoria Hospital, Blackpool, United Kingdom

Status

Recruiting

Address

Blackpool Victoria Hospital

Blackpool, , FY3 8NR

Kent and Canterbury Hospital, Canterbury, United Kingdom

Status

Recruiting

Address

Kent and Canterbury Hospital

Canterbury, , CT1 3NG

Western General Hospital, Edinburgh, United Kingdom

Status

Recruiting

Address

Western General Hospital

Edinburgh, , EH4 2XU

Imperial College Healthcare, London, United Kingdom

Status

Recruiting

Address

Imperial College Healthcare

London, , W2 1NY