🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05083169
Active, not recruiting Phase 3

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

NCT05083169 · tracked via the Priya Life Science China tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2021-10-14
Last updated
2026-08-28

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Daratumumab →Pomalidomide →Dexamethasone →Bortezomib →Teclistamab →

Daratumumab: Daratumumab will be administered SC injection.

Pomalidomide: Pomalidomide will be administered orally.

Dexamethasone: Dexamethasone will be administered orally or intravenously.

Bortezomib: Bortezomib will be administered SC injection.

Teclistamab: Teclistamab will be administered SC injection.

Study summary

The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Documented multiple myeloma as defined by the criteria: a. multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria, b. measurable disease at screening as defined by any of the following: 1) serum M-protein level greater than or equal to (\>=) 0.5 gram per deciliter (g/dL); or 2) urine M-protein level \>=200 milligrams (mg)/24 hours; or 3) serum immunoglobulin free light chain \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio * Received 1 to 3 prior line(s) of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide; a. participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory. Stable disease or progression on or within 60 days of the last dose of lenalidomide given as maintenance will meet this criterion * Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen * Have an eastern cooperative oncology group (ECOG) performance status score of 0, 1, or 2 at screening and prior to the start of administration of study treatment * Have clinical laboratory values within the specified range Exclusion Criteria: * Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients. Additional exclusion criteria pertaining to specific study drugs include: 1. A participant is not eligible to receive daratumumab subcutaneous (SC) in combination with pomalidomide and dexamethasone (DPd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide, 2) Disease that is considered refractory to pomalidomide per IMWG, 2. A participant is not eligible to receive daratumumab SC in combination with bortezomib and dexamethasone (DVd) as control therapy if any of the following are present: 1) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib, 2) Grade 1 peripheral neuropathy with pain or Grade \>= 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, 3) Disease that is considered refractory to bortezomib per IMWG, 4) Received a strong cytochromes P450 (CYP3A4) inducer within 5 half-lives prior to randomization * Received any prior B cell maturation antigen (BCMA)-directed therapy * Has disease that is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody per IMWG * Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within 14 days before randomization * Received a live, attenuated vaccine within 4 weeks before randomization * Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis

Primary outcome measure(s)

Trial sites (176)

FacilityCityRegionStatus
University of Alabama Birmingham Birmingham Alabama
City of Hope Duarte California
Stanford University Medical Center Stanford California
Yale University New Haven Connecticut
Emory University Winship Cancer Institute Atlanta Georgia
Tufts Medical Center Boston Massachusetts
Henry Ford Hospital Detroit Michigan
Henry Ford Health System Southfield Michigan
Cleveland Clinic Cleveland Ohio
West Penn Hospital Pittsburgh Pennsylvania
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Medical University of South Carolina Charleston South Carolina
Baptist Cancer Center Memphis Tennessee
Vanderbilt Ingram Cancer Center Nashville Tennessee
University of Texas Southwestern Medical Center Dallas Texas
Huntsman Cancer Institute Salt Lake City Utah
Fred Hutchinson Cancer Center Seattle Washington
University of Wisconsin Carbone Cancer Center Madison Wisconsin
Hospital Italiano de Buenos Aires Buenos Aires Argentina
Hospital Aleman CABA Argentina
Hospital Privado Centro Medico de Cordoba Córdoba Argentina
ZAS Cadix Antwerp Belgium
AZ St.-Jan Brugge-Oostende AV Bruges Belgium
UZ Gent Ghent Belgium
Hopital de Jolimont Haine Saint Paul La Louviere Belgium
Az Groeninge Kortrijk Belgium
UZ Leuven Leuven Belgium
Algemeen Ziekenhuis Delta Roeselare Belgium
Hospitais Integradaos da Gavea S/A - DF Star Brasília Brazil
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer Curitiba Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina CEPEN Florianópolis Brazil
Liga Norte Riograndense Contra O Cancer Natal Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI) Rio de Janeiro Brazil
IDOR - Regional Bahia Salvador Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia São Paulo Brazil
Hospital Paulistano São Paulo Brazil
Clinica Medica Sao Germano LTDA São Paulo Brazil
Instituto D Or de Pesquisa e Ensino IDOR São Paulo Brazil
Arthur J E Child Comprehensive Cancer Centre Calgary Alberta

+ 136 more sites — see the full list on the official registry below.

On this site

📄 Darzalex (daratumumab) drug profile →

More Janssen Research & Development, LLC trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05083169 on ClinicalTrials.gov ↗ ← All trials in China