Clinical trial NCT04722146: A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma
Official title: A Multi-arm Phase 1b Study of Teclistamab 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: 2021-01-25
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.


Eligibility criteria: Inclusion Criteria:

* Have documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
* Meet treatment regimen-specific requirements as follows: Treatment Regimen A (teclistamab \[tec\]-daratumumab \[dara\]-pomalidomide \[pom\]) only: Participant has relapsed or refractory multiple myeloma and has received 1 to 3 prior lines of therapy, including exposure to a proteasome inhibitor (PI) and lenalidomide; Treatment Regimen B (tec-dara-lenalidomide \[len\]-bortezomib \[bor\]) only: Participant has newly diagnosed or relapsed/refractory multiple myeloma and is naive to treatment with lenalidomide; Treatment Regimen C (tec-nirogacestat \[niro\]) only: Participant has relapsed or refractory multiple myeloma and has 1) received 3 or more prior lines of therapy or 2) is double refractory to a PI and an immunomodulatory drug (IMiD) and triple exposed to a PI, an IMiD, and an anti-cluster of differentiation (CD)38 monoclonal antibody (mAb); Treatment Regimen D (tec-len) only: Participant has multiple myeloma and has received greater than or equal to (\>=) 2 prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb; Treatment Regimen E (tec-dara-len) only: Participant has newly diagnosed multiple myeloma or if previously treated has received 1 to 3 prior lines of therapy, including exposure to a PI and an IMiD; Treatment Regimen F (tec-dara-len-bor) only: Participant has newly diagnosed multiple myeloma
* Have measurable disease at screening as defined by at least one of the following: serum M-protein level \>= 1.0 gram/deciliter (g/dL); or urine M-protein level \>= 200 milligrams (mg)/24 hours; or light chain multiple myeloma: serum immunoglobulin (Ig) free light chain (FLC) \>= 10 milligram/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
* A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[hCG\]) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration and must agree to further serum or urine pregnancy tests during the study
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 6 months after the last dose of study treatment

Exclusion Criteria:

* Prior treatment with any therapy that targets B-cell maturation antigen (BCMA): This exclusion does not apply to Treatment Regimen C
* Live, attenuated vaccine within 30 days 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

Primary outcomes:
measure: Number of Participants with Incidence of Adverse Events (AEs)
timeFrame: Up to 2 year and 5 months
measure: Number of Participants with AEs by Severity
timeFrame: Up to 2 year and 5 months
measure: Number of Participants with Abnormalities in Laboratory Values
timeFrame: Up to 2 year and 5 months
measure: Number of Participants with Dose-Limiting Toxicity (DLT)
timeFrame: Up to Cycle 2 Day 21 (each cycle is of 28 days for Treatment Regimen A and 21 days for Treatment Regimen B)
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 2 year and 5 months
measure: Very Good Partial Response (VGPR) or Better Response Rate
timeFrame: Up to 2 year and 5 months
measure: Complete Response (CR) or Better Response Rate
timeFrame: Up to 2 year and 5 months
measure: Stringent Complete Response (sCR) Rate
timeFrame: Up to 2 year and 5 months
measure: Duration of Response
timeFrame: Up to 2 year and 5 months
measure: Time to Response
timeFrame: Up to 2 year and 5 months
measure: Serum Concentrations of Teclistamab
timeFrame: Up to 2 year and 5 months
measure: Serum Concentrations of Daratumumab
timeFrame: Up to 2 year and 5 months
measure: Serum Concentrations of Nirogacestat
timeFrame: Up to 2 year and 5 months
measure: Number of Participants with Presence of Anti-Drug Antibodies to Teclistamab
timeFrame: Up to 2 year and 5 months
measure: Number of Participants with Presence of Anti-Drug Antibodies to Daratumumab
timeFrame: Up to 2 year and 5 months
measure: Number of Participants with Presence of Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20)
timeFrame: Up to 2 year and 5 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at 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 Melvin and Bren Simon Cancer Center
state: Indiana
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
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: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
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: Waratah
country: Australia
facility: Calvary Mater Newcastle Hospital
city: Edegem
country: Belgium
facility: UZA
city: Gent
country: Belgium
facility: UZ Gent
city: Lyon Cedex 8
country: France
facility: Centre Leon Berard
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: London
country: United Kingdom
facility: University College Hospital
city: Manchester
country: United Kingdom
facility: The Christie Nhs Foundation Trust
city: Surrey
country: United Kingdom
facility: The Royal Marsden NHS Trust Sutton
Study officials:
affiliation: Janssen Research and Development LLC
name: Janssen Research and Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: