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Clinical Trials in the UK / NCT05050097
Active, not recruiting Phase 1

A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma

NCT05050097 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 1
Started
2021-09-22
Last updated
2026-09-28

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Talquetamab →Carfilzomib →Daratumumab SC →Lenalidomide →Pomalidomide →

Talquetamab: Talquetamab will be administered subcutaneously.

Carfilzomib: Carfilzomib will be administered as an IV infusion.

Daratumumab SC: Daratumumab will be administered subcutaneously.

Lenalidomide: Lenalidomide will be self-administered orally.

Pomalidomide: Pomalidomide will be self-administered orally.

Study summary

The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria * Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level \>= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio * Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration * A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration * Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program Exclusion Criteria: * Live, attenuated vaccine within 4 weeks before the first dose of study treatment * Received a cumulative dose of corticosteroids equivalent to \>=140 mg of prednisone within the 14-day period before the start of study treatment administration * Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required * Known to be seropositive for human immunodeficiency virus * History of stroke or seizure within 6 months prior to the first dose of study treatment

Primary outcome measure(s)

  • Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability — Up to 1 year and 10 months
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
  • Number of Participants with AEs by Severity — Up to 1 year and 10 months
    Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE.
  • Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters — Up to 1 year and 6 months
    Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported.
  • Number of Participants with Dose Limiting Toxicity (DLT) — Up to 49 days
    Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity of grade 3 or higher, clinical laboratory abnormalities, or hematologic toxicity.

Trial sites (31)

FacilityCityRegionStatus
University of Alabama Birmingham Birmingham Alabama
University of California San Francisco San Francisco California
Colorado Blood Cancer Institute Denver Colorado
Emory University Atlanta Georgia
Indiana University Indianapolis Indiana
Hackensack University Medical Center Hackensack New Jersey
Mt. Sinai School of Medicine New York New York
Weill Cornell Medical College New York New York
Levine Cancer Institute Charlotte North Carolina
University of Pittsburgh Medical Center Pittsburgh Pennsylvania
Tennessee Oncology Nashville Tennessee
Medical College Of Wisconsin Milwaukee Wisconsin
St Vincents Hospital Melbourne Fitzroy Australia
Alfred Health Melbourne Australia
Gold Coast University Hospital Southport Australia
Wollongong Hospital Wollongong Australia
Cliniques Universitaires St-Luc Brussels Belgium
UZA Edegem Belgium
UZ Gent Ghent Belgium
UZ Leuven Leuven Belgium
CHU Nantes Nantes France
CHU de Bordeaux - Hospital Haut-Leveque Pessac France
Chu Rennes Hopital Pontchaillou Rennes France
Institut Universitaire du cancer de Toulouse-Oncopole Toulouse France
UMCG Groningen Netherlands
Maastricht University Medical Centre Maastricht Netherlands
UMCU Utrecht Netherlands
University College Hospital London London United Kingdom
The Christie Nhs Foundation Trust Manchester United Kingdom
Churchill Hospital Oxford United Kingdom
The Royal Marsden NHS Trust Sutton Surrey United Kingdom

On this site

📄 Revlimid (lenalidomide) drug profile →

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Other trials for the same condition

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma Recruiting
A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments Recruiting
A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma Active, not recruiting
A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant Recruiting
Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting
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 NCT05050097 on ClinicalTrials.gov ↗ ← All trials in the UK