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NCT05552222 | Recruiting | Multiple Myeloma


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
Sponsor:

Janssen Research & Development, LLC

Brief Summary:

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).

Condition or disease

Multiple Myeloma

Intervention/treatment

Teclistamab

Daratumumab

Lenalidomide

Dexamethasone

Talquetamab

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 1590 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy
Actual Study Start Date : October 25, 2022
Estimated Primary Completion Date : April 30, 2031
Estimated Study Completion Date : August 29, 2033
Arm Intervention/treatment

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

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

Drug: Teclistamab

Drug: Daratumumab

Drug: Lenalidomide

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

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

Drug: Daratumumab

Drug: Lenalidomide

Drug: Talquetamab

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

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

Drug: Daratumumab

Drug: Lenalidomide

Drug: Dexamethasone

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 40 milligrams [mg] of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (>=)20 mg of dexamethasone during the Screening Phase
  • 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

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

Location Details


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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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

Australia,

Royal Prince Alfred Hospital

Camperdown, Australia, 2050

Recruiting

Australia,

Barwon Health - University Hospital Geelong

Geelong, Australia, 3220

Recruiting

Australia,

Calvary Mater Newcastle Hospital

New South Wales, Australia, 2298

Recruiting

Australia,

Wollongong Hospital

Wollongong, Australia, 2500

Recruiting

Australia,

Princess Alexandra Hospital

Woolloongabba, Australia, 4102

Recruiting

Belgium,

Institut Jules Bordet

Anderlecht, Belgium, 1070

Recruiting

Belgium,

Jolimont

Haine-Saint-Paul, La Louviere, Belgium, 7100

Recruiting

Belgium,

Az Groeninge

Kortrijk, Belgium, 8500

Recruiting

Belgium,

Universitair Ziekenhuis Leuven

Leuven, Belgium, 3000

Recruiting

Belgium,

GZA Ziekenhuizen- Campus St Augustinus

Wilrijk, Belgium, 2610

Recruiting

Czechia,

Fakultni nemocnice Brno

Brno - Bohunice, Czechia, 625 00

Recruiting

Czechia,

Fakultni nemocnice Hradec Kralove

Hradec Kralove, Czechia, 500 05

Recruiting

Czechia,

Fakultni nemocnice Plzen

Plzen, Czechia, 304 60

Recruiting

France,

APHP - Hopital Henri Mondor

Creteil, France, 94010

Recruiting

France,

Hopital Claude Huriez

Lille, France, 59000

Recruiting

France,

CHU Nantes

Nantes, France, 44093

Recruiting

France,

CHU de Bordeaux - Hospital Haut-Leveque

Pessac cedex, France, 33604

Recruiting

France,

CHU Lyon Sud

Pierre-Benite, France, 69310

Recruiting

France,

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France, 31000

Recruiting

Germany,

Klinikum Nuernberg Nord

Nuernberg, Germany, 90419

Recruiting

Italy,

A O U Sant Orsola Malpighi

Bologna, Italy, 40138

Recruiting

Italy,

Ospedale San Raffaele

Milan, Italy, 20132

Recruiting

Italy,

IRCCS Policlinico San Matteo, Università degli studi di Pavi

Pavia, Italy, 27100

Recruiting

Italy,

Istituto Clinico Humanitas

Rozzano, Italy, 20089

Recruiting

Italy,

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino, Italy, 10126

Recruiting

Korea, Republic of,

Pusan National University Hospital

Busan, Korea, Republic of, 49241

Recruiting

Korea, Republic of,

National Cancer Center

Goyang si, Korea, Republic of, 10408

Recruiting

Netherlands,

VUMC Amsterdam

Amsterdam, Netherlands, 1081 HV

Recruiting

Netherlands,

Gelre Ziekenhuis

Apeldoorn, Netherlands, 7334 DZ

Recruiting

Netherlands,

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Netherlands, 3435 CM

Recruiting

Poland,

Pratia Onkologia Katowice

Katowice, Poland, 40-519

Recruiting

Poland,

Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

Kielce, Poland, 25-734

Recruiting

Spain,

Hosp. Univ. Virgen de Las Nieves

Granada, Spain, 18014

Recruiting

Spain,

Hosp. Univ. 12 de Octubre

Madrid, Spain, 28041

Recruiting

Spain,

Hosp. Univ. La Paz

Madrid, Spain, 28046

Recruiting

Spain,

Hosp. Univ. Hm Sanchinarro

Madrid, Spain, 28050

Recruiting

Spain,

Hosp. Univ. Son Espases

Palma de Mallorca, Spain, 07120

Recruiting

Spain,

Hosp. Clinico Univ. de Salamanca

Salamanca, Spain, 37007

Recruiting

Spain,

Hosp. Mutua Terrassa

Terrassa, Spain, 08221

Recruiting

Spain,

Hosp. Clinico Univ. de Valencia

Valencia, Spain, 46010

Recruiting

Sweden,

Falu Lasarett

Falun, Sweden, 791 82

Recruiting

Sweden,

Skanes universitetssjukhus

Lund, Sweden, 221 85

Recruiting

Sweden,

Karolinska University Hospital, Huddinge

Stockholm, Sweden, 141 86

Recruiting

Sweden,

Universitetssjukhuset Orebro

Örebro, Sweden, 701 85

Recruiting

Switzerland,

INSELSPITAL, Universitätsspital Bern

Bern, Switzerland, 3010

Recruiting

Switzerland,

Kantonsspital St.Gallen

St. Gallen, Switzerland, 9007

Recruiting

Turkey,

Ankara University Medical Faculty

Ankara, Turkey, 06590

Completed

Turkey,

Dokuz Eylul University Medical Faculty

Izmir, Turkey, 35340

Recruiting

Turkey,

Ondokuz Mayis University

Samsun, Turkey, 55280

Recruiting

United Kingdom,

Blackpool Victoria Hospital

Blackpool, United Kingdom, FY3 8NR

Recruiting

United Kingdom,

Kent and Canterbury Hospital

Canterbury, United Kingdom, CT1 3NG

Recruiting

United Kingdom,

Western General Hospital

Edinburgh, United Kingdom, EH4 2XU

Recruiting

United Kingdom,

Imperial College Healthcare

London, United Kingdom, W2 1NY

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