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
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)
Progression Free Survival (PFS) — Up to 5 years PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.
Trial sites (176)
Facility
City
Region
Status
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.
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.
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