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)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.