Clinical trial NCT05050097: A Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Official title: A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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 outcomes:
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to 1 year and 10 months
measure: Number of Participants with AEs by Severity
timeFrame: Up to 1 year and 10 months
measure: Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
timeFrame: Up to 1 year and 6 months
measure: Number of Participants with Dose Limiting Toxicity (DLT)
timeFrame: Up to 49 days
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 1 year and 10 months
measure: Very Good Partial Response (VGPR) or Better Response Rate
timeFrame: Up to 1 year and 10 months
measure: Complete Response (CR) or Better Response Rate
timeFrame: Up to 1 year and 10 months
measure: Stringent Complete Response (sCR)
timeFrame: Up to 1 year and 10 months
measure: Duration of Response
timeFrame: Up to 1 year and 10 months
measure: Time to Response
timeFrame: Up to 1 year and 10 months
measure: Serum Concentration of Talquetamab
timeFrame: Up to 1 year and 10 months
measure: Serum Concentration of Daratumumab
timeFrame: Up to 1 year and 10 months
measure: Number of Participants with Anti-Drug Antibodies to Talquetamab
timeFrame: Up to 1 year and 10 months
measure: Number of Participants with Anti-Drug Antibodies to Daratumumab
timeFrame: Up to 1 year and 10 months
measure: Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
timeFrame: Up to 1 year and 10 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Mt. Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne
city: Melbourne
country: Australia
facility: Alfred Health
city: Southport
country: Australia
facility: Gold Coast University Hospital
city: Wollongong
country: Australia
facility: Wollongong Hospital
city: Brussel
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Edegem
country: Belgium
facility: UZA
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Nantes Cedex 1
country: France
facility: CHU Nantes
city: Pessac cedex
country: France
facility: CHU de Bordeaux - Hospital Haut-Leveque
city: Rennes
country: France
facility: Chu Rennes Hopital Pontchaillou
city: TOULOUSE Cedex 9
country: France
facility: Institut Universitaire du cancer de Toulouse-Oncopole
city: Groningen
country: Netherlands
facility: UMCG
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Utrecht
country: Netherlands
facility: UMCU
city: London
country: United Kingdom
facility: University College Hospital London
city: Manchester
country: United Kingdom
facility: The Christie Nhs Foundation Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Surrey
country: United Kingdom
facility: The Royal Marsden NHS Trust Sutton
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: