🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05572515
Active, not recruiting Phase 3

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

NCT05572515 · tracked via the Priya Life Science China tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 3
Started
2023-03-29
Last updated
2026-04-13

Condition(s) studied

Relapsed or Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

TeclistamabPomalidomideBortezomibDexamethasoneCarfilzomib

Teclistamab: Teclistamab will be administered subcutaneously.

Pomalidomide: Pomalidomide will be administered orally.

Bortezomib: Bortezomib will be administered subcutaneously.

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

Carfilzomib: Carfilzomib will be administered intravenously.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (211)

FacilityCityRegionStatus
Alaska Oncology and Hematology LLC Anchorage Alaska
Banner MD Anderson Cancer Center Gilbert Arizona
Alta Bates Comprehensive Cancer Center Berkeley California
MemorialCare Long Beach Medical Center Long Beach California
University of California Irvine Orange California
PIH Health Hospital Whittier California
Rocky Mountain Cancer Centers Aurora Colorado
University of Connecticut Farmington Connecticut
University of Miami Sylvester Cancer Center Miami Florida
Orlando Health Cancer Institute Orlando Florida
Cleveland Clinic Florida Weston Florida
Mission Cancer Blood Waukee Iowa
East Jefferson General Hospital Bone Marrow Transport Clinic Metairie Louisiana
Walter Reed National Military Medical Center Bethesda Maryland
Maryland Oncology Hematology P A Silver Spring Maryland
Boston University Medical Center Boston Massachusetts
Saint Lukes Hospital Saint Lukes Cancer Specialists Chesterfield Missouri
Cooper Health System MD Anderson Cancer Center at Cooper Camden New Jersey
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center New York New York
Durham VAMC Durham North Carolina
Penn Medicine Lancaster General Health Lancaster Pennsylvania
Tennessee Oncology Nashville Tennessee
Brooke Army Medical Center Fort Sam Houston Texas
Baylor College of Medicine Houston Texas
Michael E DeBakey VA Medical Center Houston Texas
Harris Health Smith Clinic Houston Texas
Utah Cancer Specialists Salt Lake City Utah
Alexander T. Augusta Military Medical Center Fort Belvoir Virginia
Virginia Oncology Associates Norfolk Virginia
NorthWest Medical Specialties, PLLC Tacoma Washington
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

+ 171 more sites — see the full list on the official registry below.

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 NCT05572515 on ClinicalTrials.gov ↗ ← All trials in China