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ACTIVE NOT RECRUITING

NCT05572515

PHASE3

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy of teclistamab with PVd/Kd in Part 1 and to further characterize safety and efficacy of an alternative dosing for teclistamab in Part 2 in participants with relapsed or refractory multiple myeloma.

Official title: A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

614

Start Date

2023-03-29

Completion Date

2031-08-31

Last Updated

2026-04-13

Healthy Volunteers

Conditions

Relapsed or Refractory Multiple Myeloma

Interventions

DRUG

Teclistamab

Teclistamab will be administered subcutaneously.

DRUG

Pomalidomide

Pomalidomide will be administered orally.

DRUG

Bortezomib

Bortezomib will be administered subcutaneously.

DRUG

Dexamethasone

Dexamethasone will be administered orally in PVd and intravenously or orally in Kd.

DRUG

Carfilzomib

Carfilzomib will be administered intravenously.

Inclusion Criteria: * Documented diagnosis of multiple myeloma as defined by the criteria below: (a)Multiple myeloma diagnosis according to 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 grams per deciliter (g/dL) (central laboratory); or (2) Urine M-protein level \>=200 milligrams (mg)/24 hours (central laboratory); or (3) Serum immunoglobulin free light chain \>=10 milligrams per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain ratio * Received 1 to 3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti- cluster of differentiation 38 (CD38) monoclonal antibody at the approved dosing regimen in any prior line and 2 consecutive cycles of lenalidomide in any prior line * Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by International myeloma working group (IMWG) criteria * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 * A female participant must agree not to be pregnant, breast-feeding, or plan to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment * Must be willing and able to adhere to the lifestyle restrictions specified in this protocol Exclusion Criteria: * Received any prior B cell maturation antigen (BCMA)-directed therapy * A participant is not eligible to receive PVd as control therapy if any of the following are present: (1) Received prior pomalidomide therapy, (2) Does not meet criteria for bortezomib retreatment (3) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to pomalidomide or bortezomib, (4) Grade 1 peripheral neuropathy with pain or Grade greater than or equal to (\>=) 2 peripheral neuropathy as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0, (5) Received a strong cytochrome P (CYP) 3A4 inducer within 5 half-lives prior to randomization; A participant is not eligible to receive Kd as control therapy if any of the following are present:(1) Received prior carfilzomib therapy, (2) Uncontrolled hypertension, defined as an average systolic blood pressure greater than (\>)159 millimeters of mercury (mmHg) or diastolic blood pressure \>99 mmHg despite optimal treatment (3) Grade 2 peripheral neuropathy with pain or Grade \>=3 peripheral neuropathy as defined by NCI-CTCAE Version 5.0, (4) Contraindications or life-threatening allergies, hypersensitivity, or intolerance to carfilzomib (intolerance defined as prior therapy discontinued due to any adverse event \[AE\] related to carfilzomib) * Received a maximum cumulative dose of corticosteroids of \>=140 mg of prednisone or equivalent within 14 days prior to randomization * Received a live, attenuated vaccine within 4 weeks before randomization * Central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma * Plasma cell leukemia at the time of screening, Waldenstrom's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein (POEMS) syndrome and skin changes, or primary amyloid light chain amyloidosis

Locations (211)

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

MemorialCare Long Beach Medical Center

Long Beach, California, United States

University of California Irvine

Orange, California, United States

PIH Health Hospital

Whittier, California, United States

Rocky Mountain Cancer Centers

Aurora, Colorado, United States

University of Connecticut

Farmington, Connecticut, United States

University of Miami Sylvester Cancer Center

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Cleveland Clinic Florida

Weston, Florida, United States

Mission Cancer Blood

Waukee, Iowa, United States

East Jefferson General Hospital Bone Marrow Transport Clinic

Metairie, Louisiana, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Maryland Oncology Hematology P A

Silver Spring, Maryland, United States

Boston University Medical Center

Boston, Massachusetts, United States

Saint Lukes Hospital Saint Lukes Cancer Specialists

Chesterfield, Missouri, United States

Cooper Health System MD Anderson Cancer Center at Cooper

Camden, New Jersey, United States

Herbert Irving Comprehensive Cancer Center Columbia University Medical Center

New York, New York, United States

Durham VAMC

Durham, North Carolina, United States

Penn Medicine Lancaster General Health

Lancaster, Pennsylvania, United States

Tennessee Oncology

Nashville, Tennessee, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Michael E DeBakey VA Medical Center

Houston, Texas, United States

Harris Health Smith Clinic

Houston, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Alexander T. Augusta Military Medical Center

Fort Belvoir, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

NorthWest Medical Specialties, PLLC

Tacoma, Washington, United States

Blacktown Hospital

Blacktown, Australia

St Vincents Hospital Melbourne

Fitzroy, Australia

Box Hill Hospital

Melbourne, Australia

Fiona Stanley Hospital

Murdoch, Australia

Sir Charles Gairdner Hospital

Nedlands, Australia

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, Austria

Medical University Vienna MUV

Vienna, Austria

Algemeen Ziekenhuis Klina

Brasschaat, Belgium

Jolimont

Haine-St-Paul, Belgium

Az Groeninge

Kortrijk, Belgium

Universitair Ziekenhuis Gasthuisberg

Leuven, Belgium

CHR de la Citadelle

Liège, Belgium

Hospitais Integradaos da Gavea S/A - DF Star

Brasília, Brazil

Fundacao Universidade de Caxias do Sul

Caxias do Sul, Brazil

Liga Paranaense de Combate ao Cancer

Curitiba, Brazil

Instituto Joinvilense de Hematologia e Oncologia Ltda Centro de Hematologia e Oncologia

Joinville, Brazil

Liga Norte Riograndense Contra O Cancer

Natal, Brazil

Complexo Hospitalar de Niteroi

Niterói, Brazil

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, Brazil

Hospital Sao Rafael

Salvador, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, Brazil

Sociedade Beneficente de Senhoras Hospital Sirio Libanes

São Paulo, Brazil

Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil

Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, Brazil

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, Brazil

Clinica Medica Sao Germano LTDA

São Paulo, Brazil

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Brampton Civic Hospital

Brampton, Ontario, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada

Beijing Chaoyang Hospital

Beijing, China

BeiJing JiShuiTan Hospital

Beijing, China

The First Bethune Hospital of Jilin University

Changchun, China

The Third Xiangya Hospital, Central South University

Changsha, China

Sichuan Provincial Peoples Hospital

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Fujian Meidical University Union Hospital

Fuzhou, China

Sun Yat -Sen University Cancer Center

Guangzhou, China

First affiliated Hospital of Zhejiang University 1

Hangzhou, China

First affiliated Hospital of Zhejiang University

Hangzhou, China

Harbin medical university cancer hospital

Harbin, China

The First Affiliated Hospital of NanChang University

Nanchang, China

Nanjing Drum Tower Hospital

Nanjing, China

First Affiliated Hospital of Guangxi Medical University

Nanning, China

Shanghai Fourth People s Hospital

Shanghai, China

Shengjing Hospital Of China Medical University

Shenyang, China

Shenzhen 2nd People's Hospital

Shenzhen, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Institute of Hematology and Blood Diseases Hospital

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Wuhan Union Hospital

Wuhan, China

Wuxi People s Hospital

Wuxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China

Fakultni nemocnice Brno

Brno, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni Nemocnice Ostrava

Ostrava - Poruba, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Regionshospitalet Godstrup

Herning, Denmark

Odense Universitetshospital

Odense C, Denmark

Vejle Sygehus

Vejle, Denmark

CHU Amiens - Hopital Sud

Amiens, France

Hôpital Côte de Nacre

Caen, France

CHU Grenoble

Grenoble, France

And 111 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (211)