Multiple Myeloma Clinical Trial

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

Summary

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

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Full Description

Teclistamab is a full-size, immunoglobin G4 proline, alanine, alanine (IgG4-PAA) bispecific antibody that targets the cluster of differentiation 3 (CD3) receptor expressed on the surface of T cells and B cell maturation antigen (BCMA). Talquetamab is a full-size, humanized IgG4-PAA bispecific antibody designed to target the CD3 receptor complex on T cells and G protein-coupled receptor class C group 5 member D (GPRC5D), which is a 7-transmembrane receptor protein that is classified as a type C G protein-coupled receptor. DRd is an approved regimen for the treatment of participants with newly diagnosed, transplant-ineligible multiple myeloma. The primary hypothesis of this study is that Tec-DR and Tal-DR will significantly improve progression free survival (PFS) or the rate of sustained minimal residual disease (MRD)-negative complete response (CR) (greater than [>]12 months) compared with DRd in participants with newly diagnosed multiple myeloma who are ineligible or not intended for autologous stem cell transplant (ASCT) as initial therapy. The study will be conducted in 3 phases: Screening, Treatment, and Follow-up. Safety Assessment includes adverse events (AEs), laboratory test results, vital sign measurements, physical examination findings, assessment of Eastern Cooperative Oncology Group (ECOG) performance status grade, and immune effector cell associated encephalopathy (ICE) score (Tec-DR and Tal-DR).

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Eligibility 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 3 months 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

1590

Study ID:

NCT05552222

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 33 Locations for this study

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Calvary Mater Newcastle Hospital
New South Wales , 2298, Australia
Wollongong Hospital
Wollongong , 2500, Australia
Jolimont
Haine-Saint-Paul, La Louviere , 7100, Belgium
Az Groeninge
Kortrijk , 8500, Belgium
Universitair Ziekenhuis Leuven
Leuven , 3000, Belgium
GZA Ziekenhuizen- Campus St Augustinus
Wilrijk , 2610, Belgium
APHP - Hopital Henri Mondor
Creteil , 94010, France
Hopital Claude Huriez
Lille , 59000, France
CHU Nantes
Nantes , 44093, France
CHU de Bordeaux - Hospital Haut-Leveque
Pessac cedex , 33604, France
CHU Lyon Sud
Pierre-Benite , 69310, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse , 31000, France
Tata Memorial Hospital
Bombay , 40001, India
Post Graduate Institute of Medical Education & Research (PGIMER)
Chandigarh , 16001, India
Bhagwan Mahaveer Hospital & Research Centre
Jaipur , 30201, India
Tata Medical Center
Kolkata , 70016, India
Kingsway Hospital
Nagpur , 44000, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry , 60500, India
Gelre Ziekenhuis
Apeldoorn , 7334 , Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein , 3435 , Netherlands
Hosp. Univ. Virgen de Las Nieves
Granada , 18014, Spain
Hosp. Univ. 12 de Octubre
Madrid , 28041, Spain
Hosp. Univ. La Paz
Madrid , 28046, Spain
Hosp. Univ. Hm Sanchinarro
Madrid , 28050, Spain
Hosp. Univ. Son Espases
Palma de Mallorca , 07120, Spain
Hosp. Clinico Univ. de Salamanca
Salamanca , 37007, Spain
Falu Lasarett
Falun , 791 8, Sweden
Skanes universitetssjukhus
Lund , 221 8, Sweden
Karolinska University Hospital, Huddinge
Stockholm , 141 8, Sweden
Universitetssjukhuset Orebro
Örebro , 701 8, Sweden
Ankara University Medical Faculty
Ankara , 06590, Turkey
Kent and Canterbury Hospital
Canterbury , CT1 3, United Kingdom
Imperial College Healthcare
London , W2 1N, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

1590

Study ID:

NCT05552222

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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